Primary Device ID | 00810038093727 |
NIH Device Record Key | 21f0bda1-b974-4655-8a64-5a524789ed06 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Composi-Tight® |
Version Model Number | AU400-B |
Catalog Number | AU400-B |
Company DUNS | 057647005 |
Company Name | GARRISON DENTAL SOLUTIONS, L.L.C. |
Device Count | 1 |
DM Exempt | true |
Pre-market Exempt | true |
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 | true |
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 |
Phone | 888-437-0032 |
gds@garrisondental.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00810038093727 [Primary] |
JEP | Retainer, Matrix |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00810038093727]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-05-04 |
Device Publish Date | 2020-04-24 |
00810038092539 | Original Matrix Band with Extension, Bicuspid |
00810038092522 | Original Matrix Band with Extension, Pediatric |
00810038092508 | Original Matrix Band with Extension, Molar |
00810038092782 | 3D Fusionâ„¢ Full Curve Matrix Band with Extension, Molar, Blue |
00810038092775 | 3D Fusionâ„¢ Full Curve Matrix Band with Extension, Molar, Green |
00810038092768 | 3D Fusionâ„¢ Full Curve Matrix Band with Extension, Bicuspid, Purple |
00810038092751 | 3D Fusionâ„¢ Full Curve Matrix Band with Extension, Bicuspid, Red |
00810038092744 | 3D Fusionâ„¢ Full Curve Matrix Band with Extension, Bicuspid, Gray |
00810038092683 | Gold Matrix Band with Extension, Bicuspid |
00810038092676 | Gold Matrix Band with Extension, Pediatric |
00810038092669 | Gold Matrix Band, Molar |
00810038092652 | Gold Matrix Band with Extension, Molar |
00810038092645 | Gold Matrix Band, Bicuspid |
00810038093666 | Matrix Band, Bicuspid and Small Molar |
00810038093659 | Matrix Band, Molar |
00810038093642 | Matrix Band, Bicuspid |
00810038093345 | 3D Clear Matrix Band, Tall Molar |
00810038093338 | 3D Clear Matrix Band, Bicuspid and Small Molar |
00810038093321 | 3D Clear Matrix Band, Premolar |
00810038093079 | 3D Fusionâ„¢ Wedge Refill, Large, Green |
00810038093062 | 3D Fusionâ„¢ Wedge Refill, Medium, Orange |
00810038093055 | 3D Fusionâ„¢ Wedge Refill, Small, Blue |
00810038093048 | 3D Fusionâ„¢ Wedge Refill, X-Small, Yellow |
00810038092836 | 3D Fusionâ„¢ Firm Matrix Band with Extension, Molar |
00810038092829 | 3D Fusionâ„¢ Firm Matrix Band, Large Molar |
00810038092812 | 3D Fusionâ„¢ Firm Matrix Band, Small Molar |
00810038092805 | 3D Fusionâ„¢ Firm Matrix Band with Extension, Bicuspid |
00810038092799 | 3D Fusionâ„¢ Firm Matrix Band, Bicuspid |
00810038092515 | Original Matrix Band, Molar |
00810038092492 | Original Matrix Band, Bicuspid |
00810038096445 | 3D Fusionâ„¢ Standard Student Boards Kit: (30) Full Curve Matrices, (30) Wedges, (20) FenderWedg |
00810038096421 | 3D and WedgeWands® Mini Kit: (40) M-Series Matrices, (12) WedgeWands®, (1) 3D400 Ring, (1) 3D5 |
00810038096414 | 3D Clear Complete Sectional Matrix Kit: (100) Cure-Through Matrices, (100) Cure-Through WedgeWa |
00810038096353 | 3D Fusion™ Sectional Matrix System: (80) Original Matrices, (50) Wedges, (10) FenderWedge®, ( |
00810038096346 | 3D Fusionâ„¢ Sectional Matrix System: (6) Full Curve Matrices, (6) Wedges, (1) FX400 Short Ring |
00810038096339 | 3D Fusionâ„¢ Sectional Matrix System: (25) Full Curve Matrices, (40) Wedges, (1) FX400 Short Rin |
00810038096322 | 3D Fusion™ Deluxe Student Boards Kit: (60) Full Curve Matrices, (60) Wedges, (20) FenderWedge |
00810038096308 | 3D Fusion™ Basic Student Boards Kit: (30) Full Curve Matrices, (30) Wedges, (20) FenderWedge® |
00810038096292 | 3DXR Standard Student Boards Kit: (40) 3D Fusionâ„¢ Full Curve Matrices, (40) 3D Fusionâ„¢ Wedge |
00810038096285 | 3DXR Mini Student Boards Kit: (30) 3D Fusionâ„¢ Full Curve Matrices, (40) 3D Fusionâ„¢ Wedges, ( |
00810038096278 | Gold University Kit: (30) Gold Matrices, (20) WedgeWands®, (1) AU400 G-Ring, (1) AU500 G-Ring |
00810038096261 | 3D Sectional Matrix Kit: (100) M-Series Matrices, (1) 3D400 Ring, (1) 3D500 Ring |
00810038096254 | 3DXR Sectional Matrix Kit: (150) M-Series Matrices, (1) 3DXR Ring, (1) Universal Forceps |
00810038096247 | 3DXR Student Boards Kit: (20) Slick Bands™ XR Matrices, (40) WedgeWands®, (20) FenderWedge®, |
00810038096230 | 3DXR Student Boards Kit: (60) Slick Bands™ XR Matrices, (60) WedgeWands®, (20) FenderWedge®, |
00810038096223 | Original University Kit: (75) Matrices, (1) G100 G-Ring, (1) G200 G-Ring |
00810038096216 | Gold University Matrix Band Pack: 20 Count (10) AU100, (10) AU200 |
00810038096209 | Gold University Kit: (50) Gold Matrices, (1) AU400 G-Ring, (1) AU500 G-Ring, (1) 3D500 Ring |
00810038096193 | 3D University Kit: (20) M-Series Matrices, (1) G100 G-Ring, (1) 3D500 Ring |
00810038096186 | 3D University Kit: (60) M-Series Matrices, (100) WedgeWands®, (1) 3D400 Ring, (1) 3D500 Ring |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
COMPOSI-TIGHT 85774145 4410043 Live/Registered |
Garrison Dental Solutions, Inc. 2012-11-07 |
COMPOSI-TIGHT 75247287 2135820 Dead/Cancelled |
Garrison Dental Solutions, Inc. 1997-02-25 |