Absolute Dentin™ S304
GUDID 10810000525048
10ml. Artic White Absolute Dentin™ (2 Cartridges; 20ml. Total)
PARKELL, INC.
Dental composite resin| Primary Device ID | 10810000525048 |
| NIH Device Record Key | 772785cc-5342-4cf0-99a4-d95c618cef57 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Absolute Dentin™ |
| Version Model Number | S304 |
| Catalog Number | S304 |
| Company DUNS | 009900424 |
| Company Name | PARKELL, INC. |
| Device Count | 2 |
| 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the material in a cool, dry place. For longest shelf life, refrigerate without freezing. Allow to warm to room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the material in a cool, dry place. For longest shelf life, refrigerate without freezing. Allow to warm to room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the material in a cool, dry place. For longest shelf life, refrigerate without freezing. Allow to warm to room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the material in a cool, dry place. For longest shelf life, refrigerate without freezing. Allow to warm to room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the material in a cool, dry place. For longest shelf life, refrigerate without freezing. Allow to warm to room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the material in a cool, dry place. For longest shelf life, refrigerate without freezing. Allow to warm to room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the material in a cool, dry place. For longest shelf life, refrigerate without freezing. Allow to warm to room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the material in a cool, dry place. For longest shelf life, refrigerate without freezing. Allow to warm to room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the material in a cool, dry place. For longest shelf life, refrigerate without freezing. Allow to warm to room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the material in a cool, dry place. For longest shelf life, refrigerate without freezing. Allow to warm to room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the material in a cool, dry place. For longest shelf life, refrigerate without freezing. Allow to warm to room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the material in a cool, dry place. For longest shelf life, refrigerate without freezing. Allow to warm to room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the material in a cool, dry place. For longest shelf life, refrigerate without freezing. Allow to warm to room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the material in a cool, dry place. For longest shelf life, refrigerate without freezing. Allow to warm to room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the material in a cool, dry place. For longest shelf life, refrigerate without freezing. Allow to warm to room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the material in a cool, dry place. For longest shelf life, refrigerate without freezing. Allow to warm to room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the material in a cool, dry place. For longest shelf life, refrigerate without freezing. Allow to warm to room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810000525041 [Unit of Use] |
| GS1 | 10810000525048 [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 [Absolute Dentin™]
| 00810000525065 | Absolute Dentin™ 50ml - Blue |
| 00810000525034 | Absolute Dentin™ 50ml - Tooth Shade |
| 00810000525027 | Absolute Dentin™ 50ml - Arctic White |
| 00810000525010 | Absolute Dentin™ - LV 5ml Syringe (TOOTH SHADE) |
| 00810000525003 | Absolute Dentin™ - LV 5ml Syringe (WHITE SHADE) |
| M595S3070 | Absolute Dentin™ 50ml - Blue |
| M595S3051 | 10ml. Tooth Shade Absolute Dentin™ (2 Cartridges; 20ml. Total) |
| M595S3041 | 10ml. Artic White Absolute Dentin™ (2 Cartridges; 20ml. Total) |
| M595S3010 | Absolute Dentin™ 50ml - Tooth Shade |
| M595S3000 | Absolute Dentin™ 50ml - White |
| 10810000525055 | 10ml. Tooth Shade Absolute Dentin™ (2 Cartridges; 20ml. Total) |
| 10810000525048 | 10ml. Artic White Absolute Dentin™ (2 Cartridges; 20ml. Total) |
| 00810000525560 | Absolute Dentin™ 50ml - Blue for Korea |
| 00810000525553 | Absolute Dentin™ 50ml - Tooth Shade for Korea |
| 00810000525546 | Absolute Dentin™ 50ml - Arctic White for Korea |
| 00810000525614 | 10ml. Tooth Shade Absolute Dentin™ (2 Cartridges; 20ml. Total)(Korea) |
| 00810000525607 | 10ml. Artic White Absolute Dentin™ (2 Cartridges; 20ml. Total) (Korea) |
| 10810000526939 | White Root Canal Tip for Use on S334 Mixing Tip (Pkg. of 50 pcs.) |
| 10810000526922 | Mixing Tip with Brown Base for 5ml Absolute Dentin™ Plus (Pkg. of 30 pcs.) |
| 10810000526885 | Dark Grey Intraoral Tip for Use on S302 Tip (Pkg. of 50 pcs.) |
| 10810000526878 | Yellow Intraoral Tip for Use on S302 Mixing Tip (Pkg. of 50 pcs.) |
| 10810000526861 | Mixing Tip with Yellow Base for 50ml Absolute Dentin™, Mach-2®, Mach-SLO™ & SHARP™ Wash ( |
Trademark Results [Absolute Dentin]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ABSOLUTE DENTIN 87216624 5217575 Live/Registered |
Parkell, Inc. 2016-10-26 |
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