Epic® S361UD
GUDID 10810000529350
A2 Epic®-TmpT Composite in .25-gram Unit-Dose Capsules (Pkg. of 15 Capsules)
PARKELL, INC.
Dental composite resin| Primary Device ID | 10810000529350 |
| NIH Device Record Key | c3283043-b350-4ffa-a6db-3ebd967b23fc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Epic® |
| Version Model Number | S3616UD |
| Catalog Number | S361UD |
| Company DUNS | 009900424 |
| Company Name | PARKELL, INC. |
| Device Count | 15 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Never store above 104°F (40°C). If stored in a refrigerator, allow the material to warm to room temperature before use. Do not store near eugenol-containing materials. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810000529353 [Unit of Use] |
| GS1 | 10810000529350 [Primary] |
FDA Product Code
| EBF | Material, Tooth Shade, Resin |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-08-24 |
| Device Publish Date | 2019-08-16 |
On-Brand Devices [Epic®]
| 00810000529469 | D4 Epic®-TmpT Composite in 3-gram Syringe |
| 00810000529452 | C4 Epic®-TmpT Composite in 3-gram Syringe |
| 00810000529445 | C3 Epic®-TmpT Composite in 3-gram Syringe |
| 00810000529421 | C2 Epic®-TmpT Composite in 3-gram Syringe |
| 00810000529414 | B3 Epic®-TmpT Composite in 3-gram Syringe |
| 00810000529407 | B2 Epic®-TmpT Composite in 3-gram Syringe |
| 00810000529384 | A3.5 Epic®-TmpT Composite in 3-gram Syringe |
| 00810000529360 | A3 Epic®-TmpT Composite in 3-gram Syringe |
| 00810000529346 | A2 Epic®-TmpT Composite in 3-gram Syringe |
| 00810000529315 | Incisal Epic®-TmpT Composite in 3-gram Syringe |
| 00810000529292 | B4 Epic®-TmpT Composite in 3-gram Syringe |
| 00810000529278 | A4 Epic®-TmpT Composite in 3-gram Syringe |
| 00810000529254 | A1 Epic®-TmpT Composite in 3-gram Syringe |
| 00810000529247 | B1 Epic®-TmpT Composite in 3-gram Syringe |
| M595S3690 | D4 Epic®-TmpT Composite in 3-gram Syringe |
| M595S3680 | C4 Epic®-TmpT Composite in 3-gram Syringe |
| M595S3670 | C3 Epic®-TmpT Composite in 3-gram Syringe |
| M595S366UD1 | C2 Epic®-TmpT Composite in .25-gram Unit-Dose Capsules (Pkg. of 15 Capsules) |
| M595S3660 | C2 Epic®-TmpT Composite in 3-gram Syringe |
| M595S3650 | B3 Epic®-TmpT Composite in 3-gram Syringe |
| M595S3640 | B2 Epic®-TmpT Composite in 3-gram Syringe |
| M595S363UD1 | A3.5 Epic®-TmpT Composite in .25-gram Unit-Dose Capsules (Pkg. of 15 Capsules) |
| M595S3630 | A3.5 Epic®-TmpT Composite in 3-gram Syringe |
| M595S362UD1 | A3 Epic®-TmpT Composite in .25-gram Unit-Dose Capsules (Pkg. of 15 Capsules) |
| M595S3620 | A3 Epic®-TmpT Composite in 3-gram Syringe |
| M595S361UD1 | A2 Epic®-TmpT Composite in .25-gram Unit-Dose Capsules (Pkg. of 15 Capsules) |
| M595S3610 | A2 Epic®-TmpT Composite in 3-gram Syringe |
| M595S360UD1 | Universal B2/B3 Epic®-TmpT Composite in .25-gram Unit-Dose Capsules (Pkg. of 15 Capsules) |
| M595S3600 | Universal B2/B3 Epic®-TmpT Composite in 3-gram Syringe |
| M595S3590 | Incisal Epic®-TmpT Composite in 3-gram Syringe |
| M595S3580 | B4 Epic®-TmpT Composite in 3-gram Syringe |
| M595S357UD1 | A4 Epic®-TmpT Composite in .25-gram Unit-Dose Capsules (Pkg. of 15 Capsules) |
| M595S3570 | A4 Epic®-TmpT Composite in 3-gram Syringe |
| M595S356UD1 | A1 Epic®-TmpT Composite in .25-gram Unit-Dose Capsules (Pkg. of 15 Capsules) |
| M595S3560 | A1 Epic®-TmpT Composite in 3-gram Syringe |
| M595S3550 | B1 Epic®-TmpT Composite in 3-gram Syringe |
| 10810000529305 | B4 Epic®-TmpT Composite in .25-gram Unit-Dose Capsules (Pkg. of 15 Capsules) |
| 10810000529435 | C2 Epic®-TmpT Composite in .25-gram Unit-Dose Capsules (Pkg. of 15 Capsules) |
| 10810000529398 | A3.5 Epic®-TmpT Composite in .25-gram Unit-Dose Capsules (Pkg. of 15 Capsules) |
| 10810000529374 | A3 Epic®-TmpT Composite in .25-gram Unit-Dose Capsules (Pkg. of 15 Capsules) |
| 10810000529350 | A2 Epic®-TmpT Composite in .25-gram Unit-Dose Capsules (Pkg. of 15 Capsules) |
| 10810000529336 | Universal B2/B3 Epic®-TmpT Composite in .25-gram Unit-Dose Capsules (Pkg. of 15 Capsules) |
| 10810000529329 | Universal B2/B3 Epic®-TmpT Composite in 3-gram Syringe |
| 10810000529282 | A4 Epic®-TmpT Composite in .25-gram Unit-Dose Capsules (Pkg. of 15 Capsules) |
| 10810000529268 | A1 Epic®-TmpT Composite in .25-gram Unit-Dose Capsules (Pkg. of 15 Capsules) |
Trademark Results [Epic]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EPIC 98780621 not registered Live/Pending |
FRC Global Inc. 2024-10-01 |
 EPIC 98701922 not registered Live/Pending |
Adaria Holdings Limited 2024-08-16 |
 EPIC 98673443 not registered Live/Pending |
Storyteller Overland, LLC 2024-07-30 |
 EPIC 98529384 not registered Live/Pending |
Sciton, Inc. 2024-05-01 |
 EPIC 98503407 not registered Live/Pending |
EPIC Auto, LLC 2024-04-16 |
 EPIC 98480664 not registered Live/Pending |
Sony Music Entertainment 2024-04-02 |
 EPIC 98475945 not registered Live/Pending |
Vail Trademarks, Inc. 2024-03-29 |
 EPIC 98388723 not registered Live/Pending |
EPIC Disability Advocacy 2024-02-02 |
 EPIC 98358759 not registered Live/Pending |
GEODynamics Inc. 2024-01-16 |
 EPIC 98358420 not registered Live/Pending |
akram muhammad perviz 2024-01-16 |
 EPIC 98354891 not registered Live/Pending |
Stellar Day Services, LLC 2024-01-12 |
 EPIC 98290719 not registered Live/Pending |
EPIC WEB3, INC. 2023-11-29 |
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