| Primary Device ID | 00817645020207 |
| NIH Device Record Key | b2b30a20-1b2c-43b8-a829-811151dc4b28 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Indirect Bonding Tray |
| Version Model Number | 700D |
| Company DUNS | 081365847 |
| Company Name | Six Month Smiles |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | 00817645020207 [Primary] |
| KMY | Positioner, Tooth, Preformed |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-03-24 |
| Device Publish Date | 2023-03-16 |
| 00817645020207 - Indirect Bonding Tray | 2023-03-24 |
| 00817645020207 - Indirect Bonding Tray | 2023-03-24 |
| 00817645020191 - Porcelain Conditioner | 2021-02-16 Porcelain Conditioner |
| 00817645020184 - Assure Plus | 2021-02-15 Assure Plus 2ml (Plus2ml) |
| 00817645020177 - 6MS Aligners | 2019-07-25 Dental Aligners |
| 00817645020009 - OrthoFlow® | 2018-11-16 OrthoFlow® - Indirect Bond 1.5g (Indirect Bonding) |
| 00817645020016 - OrthoMax® | 2018-11-16 OrthoMax® - Direct Bond 5g (Direct Bonding) |
| 00817645020023 - Lucid-Lok™ | 2018-11-16 Lucid-Lok™ Composite Clearlet (Pack of 10) |
| 00817645020030 - Lucid-Lok™ | 2018-11-16 Lucid-Lok™ .022 Composite Bracket 5 Set Carousel w/Metal Molar Tubes |