| Primary Device ID | 07615208459586 |
| NIH Device Record Key | ae18a146-6178-4b86-b7a4-546b87d8dedb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gnathometer M/ Gnathometer CAD |
| Version Model Number | 687679 |
| Catalog Number | 687679 |
| Company DUNS | 448015938 |
| Company Name | IVOCLAR VIVADENT AKTIENGESELLSCHAFT |
| 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 | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07615208459586 [Primary] |
| KZO | Ink, arch tracing |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07615208459586]
Moist Heat or Steam Sterilization
[07615208459586]
Moist Heat or Steam Sterilization
[07615208459586]
Moist Heat or Steam Sterilization
[07615208459586]
Moist Heat or Steam Sterilization
[07615208459586]
Moist Heat or Steam Sterilization
[07615208459586]
Moist Heat or Steam Sterilization
[07615208459586]
Moist Heat or Steam Sterilization
[07615208459586]
Moist Heat or Steam Sterilization
[07615208459586]
Moist Heat or Steam Sterilization
[07615208459586]
Moist Heat or Steam Sterilization
[07615208459586]
Moist Heat or Steam Sterilization
[07615208459586]
Moist Heat or Steam Sterilization
[07615208459586]
Moist Heat or Steam Sterilization
[07615208459586]
Moist Heat or Steam Sterilization
[07615208459586]
Moist Heat or Steam Sterilization
[07615208459586]
Moist Heat or Steam Sterilization
[07615208459586]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-04 |
| Device Publish Date | 2024-06-26 |
| 07615208488401 - OptraSculpt | 2026-01-23 OptraSculpt Refill/ Pointed Tip/ 60 |
| 07615208445596 - OptraSculpt | 2026-01-23 OptraSculpt Refill/ Chisel/ 60 |
| 07615208445602 - OptraSculpt | 2026-01-23 OptraSculpt Refill/ Ball/ 60 |
| 07615208486254 - OptraSculpt | 2026-01-23 OptraSculpt Pad Refill/6 mm/60 |
| 07615208445947 - OptraSculpt | 2026-01-23 OptraSculpt Pad Refill/4 mm/60 |
| 07615208590296 - Tetric CAD | 2026-01-21 Tetric CAD for PrograMill MT BL C14/5 |
| 07615208590258 - Tetric CAD | 2026-01-21 Tetric CAD for PrograMill MT A3.5 C14/5 |
| 07615208590265 - Tetric CAD | 2026-01-21 Tetric CAD for PrograMill MT A3 C14/5 |