| Primary Device ID | 00850061175090 |
| NIH Device Record Key | c1c72eb3-addf-4692-af5b-abee01f62d27 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Surgical Guide Resin |
| Version Model Number | FLSGAM01 |
| Company DUNS | 106744280 |
| Company Name | FORMLABS OHIO INC. |
| 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 | 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 | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850061175090 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-02 |
| Device Publish Date | 2024-04-24 |
| 00850061175007 - Premium Teeth Resin - HT Bleach | 2024-05-02 Premium Teeth Resin (HT Bleach) for cartridge v2 |
| 00850061175014 - Premium Teeth Resin - HT A2 | 2024-05-02 Premium Teeth Resin (HT A2) for cartridge v2 |
| 00850061175021 - Premium Teeth Resin - HT B1 | 2024-05-02 Premium Teeth Resin (HT B1) for cartridge v2 |
| 00850061175038 - Premium Teeth Resin - HT A3 | 2024-05-02 Premium Teeth Resin (HT A3) for cartridge v2 |
| 00850061175069 - Custom Tray Resin | 2024-05-02 Custom Tray Resin for cartridge v2 |
| 00850061175076 - Dental LT Clear V2 | 2024-05-02 Dental LT Clear V2 for cartridge V2 |
| 00850061175083 - IBT Flex Resin | 2024-05-02 IBT Flex Resin for cartridge V2 |
| 00850061175090 - Surgical Guide Resin | 2024-05-02Surgical Guide Resin for cartridge V2 |
| 00850061175090 - Surgical Guide Resin | 2024-05-02 Surgical Guide Resin for cartridge V2 |