HyperFIL® S235
GUDID 00810000525737
Hyperfil® 3ml Enamel Shade
PARKELL, INC.
Dental composite resin| Primary Device ID | 00810000525737 |
| NIH Device Record Key | 84f2624c-38f3-48c5-8f79-723bed4f5297 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HyperFIL® |
| Version Model Number | S235 |
| Catalog Number | S235 |
| 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
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excess heat and storage near eugenol containing materials. Store at room temperature in a cool, dry place. If refrigerated, bring to room temperature before use. Avoid Freezing. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excess heat and storage near eugenol containing materials. Store at room temperature in a cool, dry place. If refrigerated, bring to room temperature before use. Avoid Freezing. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excess heat and storage near eugenol containing materials. Store at room temperature in a cool, dry place. If refrigerated, bring to room temperature before use. Avoid Freezing. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excess heat and storage near eugenol containing materials. Store at room temperature in a cool, dry place. If refrigerated, bring to room temperature before use. Avoid Freezing. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excess heat and storage near eugenol containing materials. Store at room temperature in a cool, dry place. If refrigerated, bring to room temperature before use. Avoid Freezing. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excess heat and storage near eugenol containing materials. Store at room temperature in a cool, dry place. If refrigerated, bring to room temperature before use. Avoid Freezing. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excess heat and storage near eugenol containing materials. Store at room temperature in a cool, dry place. If refrigerated, bring to room temperature before use. Avoid Freezing. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excess heat and storage near eugenol containing materials. Store at room temperature in a cool, dry place. If refrigerated, bring to room temperature before use. Avoid Freezing. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excess heat and storage near eugenol containing materials. Store at room temperature in a cool, dry place. If refrigerated, bring to room temperature before use. Avoid Freezing. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excess heat and storage near eugenol containing materials. Store at room temperature in a cool, dry place. If refrigerated, bring to room temperature before use. Avoid Freezing. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excess heat and storage near eugenol containing materials. Store at room temperature in a cool, dry place. If refrigerated, bring to room temperature before use. Avoid Freezing. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excess heat and storage near eugenol containing materials. Store at room temperature in a cool, dry place. If refrigerated, bring to room temperature before use. Avoid Freezing. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excess heat and storage near eugenol containing materials. Store at room temperature in a cool, dry place. If refrigerated, bring to room temperature before use. Avoid Freezing. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excess heat and storage near eugenol containing materials. Store at room temperature in a cool, dry place. If refrigerated, bring to room temperature before use. Avoid Freezing. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excess heat and storage near eugenol containing materials. Store at room temperature in a cool, dry place. If refrigerated, bring to room temperature before use. Avoid Freezing. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excess heat and storage near eugenol containing materials. Store at room temperature in a cool, dry place. If refrigerated, bring to room temperature before use. Avoid Freezing. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excess heat and storage near eugenol containing materials. Store at room temperature in a cool, dry place. If refrigerated, bring to room temperature before use. Avoid Freezing. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excess heat and storage near eugenol containing materials. Store at room temperature in a cool, dry place. If refrigerated, bring to room temperature before use. Avoid Freezing. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excess heat and storage near eugenol containing materials. Store at room temperature in a cool, dry place. If refrigerated, bring to room temperature before use. Avoid Freezing. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excess heat and storage near eugenol containing materials. Store at room temperature in a cool, dry place. If refrigerated, bring to room temperature before use. Avoid Freezing. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excess heat and storage near eugenol containing materials. Store at room temperature in a cool, dry place. If refrigerated, bring to room temperature before use. Avoid Freezing. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excess heat and storage near eugenol containing materials. Store at room temperature in a cool, dry place. If refrigerated, bring to room temperature before use. Avoid Freezing. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excess heat and storage near eugenol containing materials. Store at room temperature in a cool, dry place. If refrigerated, bring to room temperature before use. Avoid Freezing. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excess heat and storage near eugenol containing materials. Store at room temperature in a cool, dry place. If refrigerated, bring to room temperature before use. Avoid Freezing. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excess heat and storage near eugenol containing materials. Store at room temperature in a cool, dry place. If refrigerated, bring to room temperature before use. Avoid Freezing. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excess heat and storage near eugenol containing materials. Store at room temperature in a cool, dry place. If refrigerated, bring to room temperature before use. Avoid Freezing. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excess heat and storage near eugenol containing materials. Store at room temperature in a cool, dry place. If refrigerated, bring to room temperature before use. Avoid Freezing. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excess heat and storage near eugenol containing materials. Store at room temperature in a cool, dry place. If refrigerated, bring to room temperature before use. Avoid Freezing. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810000525737 [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 | 2024-03-11 |
| Device Publish Date | 2024-03-01 |
On-Brand Devices [HyperFIL®]
| 00810000525737 | Hyperfil® 3ml Enamel Shade |
| 00810000525720 | Hyperfil® 3ml Universal Shade |
| 00810000525775 | HyperFIL® + A2/B2 - 10ml |
| 00810000525768 | HyperFIL® + A1/B1 - 10ml |
| 00810000525751 | HyperFIL® + A3/A3.5/B3 - 2.5ml |
| 00810000525782 | HyperFIL® + A2/B2 |
Trademark Results [HyperFIL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HYPERFIL 87217502 5214028 Live/Registered |
Parkell, Inc. 2016-10-27 |
 HYPERFIL 76431297 2969122 Live/Registered |
SULZER MANAGEMENT AG 2002-07-15 |
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