| Primary Device ID | 00850015110078 |
| NIH Device Record Key | a44954df-158e-41db-802e-dd022095748a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TEMREX CR |
| Version Model Number | 7780 |
| Company DUNS | 012072823 |
| Company Name | TEMREX CORPORATION |
| 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 | 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 | 00850015110078 [Primary] |
| EMA | Cement, Dental |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-01-24 |
| Device Publish Date | 2020-01-16 |
| 00850015110450 - TEMREX MATRIX BAND IVORY TYPE | 2022-03-17 A stainless steel band that is used to form a mould around a tooth for the insertion of restorative materials. |
| 00850015110474 - TEMREX SATIN POLISHING PASTE | 2022-03-17 For restoring the original smoothness and polishing of dental porcelain crowns, inlays, onlays, veneers and bridges; for both i |
| 00850015110498 - TEMREX BITE RELATOR | 2022-03-17 DENTAL IMPRESSION TRAY AND INSERT |
| 00850015110511 - TEMREX BITE WING TABS | 2022-03-17 DENTAL X-RAY FILM HOLDER |
| 00850015110535 - TEMREX RITE BITE TRAY | 2022-03-17 DISPOSABLE DENTAL IMPRESSION TRAY INSERT |
| 00850015110610 - TEMREX TOFFLEMIRE MATRIX BAND | 2022-03-17 A stainless steel band that is used to form a mould around a tooth for the insertion of restorative materials. |
| 00850015110627 - TEMREX MATRIX RETAINER | 2022-03-17 A dental device designed to engage the ends of a matrix band or strip to hold it in position around a tooth that is being prepar |
| 00850015110634 - TEMREX BRASS "T" MATRIX BAND | 2022-03-17 A stainless steel band that is used to form a mould around a tooth for the insertion of restorative materials. |