| Primary Device ID | D9499000412 |
| NIH Device Record Key | 2c78c0a8-bfb1-4bb8-855d-78a454c08ca2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BT, Evolve, & DW |
| Version Model Number | Samples for 3M Heaters |
| Company DUNS | 059020838 |
| Company Name | Bioclear Matrix Systems |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D9499000412 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-28 |
| Device Publish Date | 2024-08-20 |
| D9498271612 - Evolve All-in-One Select Kit | 2024-10-30 Convenience kit of Bioclear products used in posterior dental restorations. |
| D9499000412 - BT, Evolve, & DW | 2024-08-28Samples of Bioclear products used in dental restorations. |
| D9499000412 - BT, Evolve, & DW | 2024-08-28 Samples of Bioclear products used in dental restorations. |
| D9498270912 - Evolve Matrix Procedure Kit | 2024-07-18 Convenience kit of Bioclear products used in posterior dental restorations. |
| D9495000821 - Bioclear Instrument | 2024-04-15 Metal instrument used in dental restorations. |
| D9498271312 - Select Bioclear Evolve Posterior Kit | 2024-04-15 Convenience kit of Bioclear products used in posterior dental restorations. |
| D9498271412 - Bioclear Evolve Posterior Kit | 2024-04-15 Convenience kit of Bioclear products used in posterior dental restorations. |
| D949208011R1 - Bioclear TwinRing | 2023-09-25 Separator ring used in dental restorations. |
| D949208021R1 - Bioclear TwinRing | 2023-09-25 Separator ring used in dental restorations. |