| Primary Device ID | 00810038090467 |
| NIH Device Record Key | 74ed1c45-280b-4a62-bfb1-fc34b4e3be68 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Composi-Tight 3D Fusion Matrix System |
| Version Model Number | FX-HHF-00-VM |
| Company DUNS | 057647005 |
| Company Name | GARRISON DENTAL SOLUTIONS, L.L.C. |
| Device Count | 1 |
| DM Exempt | false |
| 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 | 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 | 00810038090467 [Primary] |
| JEP | Retainer, Matrix |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810038090467]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-10 |
| Device Publish Date | 2022-09-30 |
| 00810038096490 - Composi-Tight 3D Fusion | 2023-08-29 Composi-Tight 3D Fusion Firm Matrix Bands Sample Kit |
| 00810038090207 - Composi-Tight 3D Fusion | 2023-08-28 Composi-Tight 3D Fusion Sectional Matrix Student Kit |
| 00810038090931 - Composi-Tight™ | 2023-08-21 Composi-Tight™ 3D Fusion Sectional Matrix System Kit |
| 00810038090962 - Strata-G™ | 2023-08-21 Strata-G™ Matrix Band Trial Kit |
| 00810038090979 - Strata-G™ | 2023-08-21 Strata-G™ Wedge Trial Kit |
| 00810038090948 - Strata-G™ | 2023-05-17 Strata-G™ Firm Sectional Matrix System Intro Kit |
| 00810038090955 - Strata-G™ | 2023-05-17 Strata-G™ Firm Sectional Matrix System Standard Kit |
| 00810038090863 - Loop™ | 2023-05-01 Loop™ Protective Light Shield |