| Primary Device ID | 07897990399213 |
| NIH Device Record Key | b33cd0c6-cde6-4a1d-9be6-51531de2037d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UNIMATRIX S |
| Version Model Number | 0003020300 |
| Catalog Number | 0003020300 |
| Company DUNS | 900580358 |
| Company Name | TDV DENTAL LTDA |
| 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 | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07897990399213 [Primary] |
| EKF | Instrument, Contouring, Matrix, Operative |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07897990399213]
Moist Heat or Steam Sterilization
[07897990399213]
Moist Heat or Steam Sterilization
[07897990399213]
Moist Heat or Steam Sterilization
[07897990399213]
Moist Heat or Steam Sterilization
[07897990399213]
Moist Heat or Steam Sterilization
[07897990399213]
Moist Heat or Steam Sterilization
[07897990399213]
Moist Heat or Steam Sterilization
[07897990399213]
Moist Heat or Steam Sterilization
[07897990399213]
Moist Heat or Steam Sterilization
[07897990399213]
Moist Heat or Steam Sterilization
[07897990399213]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-26 |
| Device Publish Date | 2026-02-18 |
| 07897990399220 | Unimatrix S – 1 ring |
| 07897990399213 | Unimatrix S – 50 sectional matrices + 2 rings |
| 07897990399091 | Unimatrix S – 25 sectional matrices + 1 ring |