| Primary Device ID | 00860270000953 |
| NIH Device Record Key | e346da1a-00de-4ad1-b9ec-e25949589b0a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Signature Custom Orthodontic Braces |
| Version Model Number | 08.23.18.1.PCA.TBW.WJ |
| Company DUNS | 096883072 |
| Company Name | LIGHTFORCE ORTHODONTICS, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| 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 | 00860270000953 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-11-05 |
| Device Publish Date | 2018-08-23 |
| 00850079555006 - FlexBracket | 2025-10-06 FlexBracket PCA UL1 022 +11 +5 |
| 00850079555013 - FlexBracket | 2025-10-06 FlexBracket PCA UL2 022 +7 +9 |
| 00850079555020 - FlexBracket | 2025-10-06 FlexBracket PCA UL3 022 0 +13 Hook |
| 00850079555037 - FlexBracket | 2025-10-06 FlexBracket PCA UL4 022 -7 0 Hook |
| 00850079555044 - FlexBracket | 2025-10-06 FlexBracket PCA UL5 022 -11 0 Hook |
| 00850079555051 - FlexBracket | 2025-10-06 FlexBracket PCA UL6 022 -21 0 Hook |
| 00850079555068 - FlexBracket | 2025-10-06 FlexBracket PCA UL7 022 -24 0 Hook |
| 00850079555075 - FlexBracket | 2025-10-06 FlexBracket PCA UR1 022 +11 +5 |