| Primary Device ID | 00190707084639 |
| NIH Device Record Key | c6339afb-f658-47eb-8613-27eea0e7033d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Band Assemblies |
| Version Model Number | 093E |
| Company DUNS | 062165188 |
| Company Name | ORTHO ORGANIZERS, INC. |
| 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 | 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 | 00190707084639 [Primary] |
| ECM | BAND, PREFORMED, ORTHODONTIC |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-21 |
| Device Publish Date | 2020-07-13 |
| 00190707084738 | Tempra Etch Second Molar Band |
| 00190707084721 | Tempra Second Molar Band |
| 00190707084714 | Tempra Etch First Molar Band |
| 00190707084707 | Tempra First Molar Band |
| 00190707084691 | Epic Etch Second Molar Band |
| 00190707084684 | Epic Second Molar Band |
| 00190707084677 | Epic First Molar Band / Etch |
| 00190707084660 | Epic First Molar Band |
| 00190707084653 | Tempra Etch Second Molar Band / Small Cleat |
| 00190707084646 | Tempra Second Molar Band / Small Cleat |
| 00190707084639 | Tempra Etch Second Molar Band / Lug |
| 00190707084622 | Tempra Second Molar Band / Lug |
| 00190707084615 | Tempra Etch Second Molar Band / Button |
| 00190707084608 | Tempra Second Molar Band / Button |
| 00190707084592 | Tempra Etch Second Molar Band / Cleat |
| 00190707084585 | Tempra Second Molar Band / Cleat |
| 00190707084578 | Tempra First Molar Band: Etched/ Sheath/ Vertical Hooks- UL/LR |
| 00190707084561 | Tempra Etch First Molar Upper Left / Sheath - Horizontal Hook |
| 00190707084554 | Tempra First Molar Upper Left Sheath - Horizontal Hook |
| 00190707084547 | Tempra First Molar Band: Etched/ Sheath/ Vertical Hooks-UR/LL |
| 00190707084530 | Tempra Etch First Molar Upper Right / Sheath - Horizontal Hook |
| 00190707084523 | Tempra First Molar Upper Right / Sheath - Horizontal Hook |
| 00190707084516 | Tempra Etch First Molar Band / Sheath - Hook |
| 00190707084509 | Tempra First Molar / Sheath - Hook |
| 00190707084493 | Tempra Etch First Molar Band / Sheath |
| 00190707084486 | Tempra First Molar / Sheath |
| 00190707084479 | Tempra Etch First Molar Band / Small Cleat |
| 00190707084462 | Tempra First Molar Band / Small Cleat |
| 00190707084455 | Tempra Etch First Molar Band / Lug |
| 00190707084448 | Molar Band/Lug Lingual/Buccal Etched |
| 00190707084431 | Tempra First Molar Band / Lug |
| 00190707084424 | Tempra Etch First Molar Band / Button |
| 00190707084417 | Molar Band/ Button Lingual/ Buccal Etch |
| 00190707084400 | Molar Band / Button Lingual/Buccal |
| 00190707084394 | Tempra First Molar Band / Button |
| 00190707084387 | Tempra Etch First Molar Band / Cleat |
| 00190707084370 | Molar Band/ Cleat Lingual/ Buccal Etch |
| 00190707084363 | Tempra First Molar Band / Cleat |
| 00190707084356 | Epic Etch Second Molar Band / Small Cleat |
| 00190707084349 | Epic Second Molar Band / Small Cleat |
| 00190707084332 | Epic Etch Second Molar Band / Lug |
| 00190707084325 | Epic Second Molar Band / Lug |
| 00190707084318 | Epic Etch Second Molar Band / Button |
| 00190707084301 | Epic Second Molar Band / Button |
| 00190707084295 | Epic Etch Second Molar Band / Cleat |
| 00190707084288 | Epic Second Molar Band / Cleat |
| 00190707084271 | Epic Etch First Molar Band / Sheath - Horizontal Hook |
| 00190707084264 | Epic First Molar Upper Left / Sheath - Horizontal Hook |
| 00190707084257 | Epic Etch First Molar Band / Sheath - Horizontal Hook |
| 00190707084240 | Epic First Molar Upper Right / Sheath - Horizontal Hook |