HyperFIL™ S326
GUDID 00810000525249
10ml Universal Shade HyperFIL™ - DC (Dual-Cure)
PARKELL, INC.
Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin| Primary Device ID | 00810000525249 |
| NIH Device Record Key | 7b1ccd83-d148-45a3-b88f-8e4e4e6f098d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HyperFIL™ |
| Version Model Number | S326 |
| Catalog Number | S326 |
| 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 3 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid excessive heat. Refrigeration will prolong the shelf life. Do not store near eugenol containing materials. 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 *Avoid excessive heat. Refrigeration will prolong the shelf life. Do not store near eugenol containing materials. 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 *Avoid excessive heat. Refrigeration will prolong the shelf life. Do not store near eugenol containing materials. 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 *Avoid excessive heat. Refrigeration will prolong the shelf life. Do not store near eugenol containing materials. 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 *Avoid excessive heat. Refrigeration will prolong the shelf life. Do not store near eugenol containing materials. 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 *Avoid excessive heat. Refrigeration will prolong the shelf life. Do not store near eugenol containing materials. 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 *Avoid excessive heat. Refrigeration will prolong the shelf life. Do not store near eugenol containing materials. 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 *Avoid excessive heat. Refrigeration will prolong the shelf life. Do not store near eugenol containing materials. 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 *Avoid excessive heat. Refrigeration will prolong the shelf life. Do not store near eugenol containing materials. 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 *Avoid excessive heat. Refrigeration will prolong the shelf life. Do not store near eugenol containing materials. 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 *Avoid excessive heat. Refrigeration will prolong the shelf life. Do not store near eugenol containing materials. 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 *Avoid excessive heat. Refrigeration will prolong the shelf life. Do not store near eugenol containing materials. 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 *Avoid excessive heat. Refrigeration will prolong the shelf life. Do not store near eugenol containing materials. 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 *Avoid excessive heat. Refrigeration will prolong the shelf life. Do not store near eugenol containing materials. 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 *Avoid excessive heat. Refrigeration will prolong the shelf life. Do not store near eugenol containing materials. 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 *Avoid excessive heat. Refrigeration will prolong the shelf life. Do not store near eugenol containing materials. 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 *Avoid excessive heat. Refrigeration will prolong the shelf life. Do not store near eugenol containing materials. 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 *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 | 00810000525249 [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 | 2018-10-26 |
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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