HyperFIL™ S231
GUDID 00810000525201
HyperFIL™ HAp Enamel Shade
PARKELL, INC.
Dental composite resin| Primary Device ID | 00810000525201 |
| NIH Device Record Key | 6291fb2c-3454-4080-9087-51268895f879 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HyperFIL™ |
| Version Model Number | S231 |
| Catalog Number | S231 |
| 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 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product tightly sealed, away from direct sunlight and eugenol containing materials. Do not freeze. Bring to room temperature before use. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product tightly sealed, away from direct sunlight and eugenol containing materials. Do not freeze. Bring to room temperature before use. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product tightly sealed, away from direct sunlight and eugenol containing materials. Do not freeze. Bring to room temperature before use. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product tightly sealed, away from direct sunlight and eugenol containing materials. Do not freeze. Bring to room temperature before use. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product tightly sealed, away from direct sunlight and eugenol containing materials. Do not freeze. Bring to room temperature before use. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product tightly sealed, away from direct sunlight and eugenol containing materials. Do not freeze. Bring to room temperature before use. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product tightly sealed, away from direct sunlight and eugenol containing materials. Do not freeze. Bring to room temperature before use. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product tightly sealed, away from direct sunlight and eugenol containing materials. Do not freeze. Bring to room temperature before use. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product tightly sealed, away from direct sunlight and eugenol containing materials. Do not freeze. Bring to room temperature before use. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product tightly sealed, away from direct sunlight and eugenol containing materials. Do not freeze. Bring to room temperature before use. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product tightly sealed, away from direct sunlight and eugenol containing materials. Do not freeze. Bring to room temperature before use. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product tightly sealed, away from direct sunlight and eugenol containing materials. Do not freeze. Bring to room temperature before use. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product tightly sealed, away from direct sunlight and eugenol containing materials. Do not freeze. Bring to room temperature before use. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product tightly sealed, away from direct sunlight and eugenol containing materials. Do not freeze. Bring to room temperature before use. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product tightly sealed, away from direct sunlight and eugenol containing materials. Do not freeze. Bring to room temperature before use. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product tightly sealed, away from direct sunlight and eugenol containing materials. Do not freeze. Bring to room temperature before use. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product tightly sealed, away from direct sunlight and eugenol containing materials. Do not freeze. Bring to room temperature before use. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product tightly sealed, away from direct sunlight and eugenol containing materials. Do not freeze. Bring to room temperature before use. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810000525201 [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 | 2019-09-20 |
| Device Publish Date | 2018-09-21 |
On-Brand Devices [HyperFIL™]
| 00810000525249 | 10ml Universal Shade HyperFIL™ - DC (Dual-Cure) |
| 00810000525232 | 10ml Enamel Shade HyperFIL™ - DC (Dual-Cure) |
| 00810000525225 | HyperFIL™ Intro Kit (Contains: Enamel & Universal HyperFIL™ plus dispensing gun) |
| 00810000525218 | HyperFIL™ HAp Universal Shade |
| 00810000525201 | HyperFIL™ HAp Enamel Shade |
| M595S3260 | 10ml Universal Shade HyperFIL™-DC (Dual-Cure) |
| M595S3230 | 10ml Enamel Shade HyperFIL™-DC (Dual-Cure) |
| M595S3210 | HyperFIL™ Intro Kit (Contains: Enamel & Universal HyperFIL™ plus 10ml Dispensing Gun & Mixin |
| 10810000526915 | White Intraoral Tip for Use on S328 Mixing Tip (Pkg. of 50 pcs.) |
| 10810000526908 | Mixing Tip with Brown Base for 10ml HyperFil™ & 10ml Absolute Dentin™ (Pkg. of 30 pcs.) |
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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