Epic® S359

GUDID 00810000529315

Incisal Epic®-TmpT Composite in 3-gram Syringe

PARKELL, INC.

Dental composite resin

• Primary Device ID: 00810000529315
• NIH Device Record Key: 4cec665d-633e-44ac-a128-b354452660d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Epic®
• Version Model Number: S359
• Catalog Number: S359
• Company DUNS: 009900424
• Company Name: PARKELL, INC.
• Device Count: 1
• 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: false
• 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

• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com

Operating and Storage Conditions

• 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.
• 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.
• 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.
• 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	00810000529315 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-03
• Device Publish Date: 2018-11-02

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)