Primary Device ID | 10810000526878 |
NIH Device Record Key | 354842eb-701f-4455-8721-b077c84e565c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Absolute Dentin™ |
Version Model Number | S303 |
Catalog Number | S303 |
Company DUNS | 009900424 |
Company Name | PARKELL, INC. |
Device Count | 50 |
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 | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00810000526871 [Unit of Use] |
GS1 | 10810000526878 [Primary] |
EBF | Material, Tooth Shade, Resin |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2022-06-03 |
Device Publish Date | 2018-09-21 |
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 ( |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ABSOLUTE DENTIN 87216624 5217575 Live/Registered |
Parkell, Inc. 2016-10-26 |