| 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 |
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| 07615208584998 - Optragate Dry Control | 2025-12-12 OptraGate Dry Control Refill / 60 |
| 07615208543506 - Optragate Dry Control | 2025-12-12 OptraGate Dry TestPack / 1x2 |
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| 07615208539226 - IPS e.max Ceram Art | 2025-12-10 IPS e.max Ceram Art Universalliquid 15ml |
| 07615208539233 - IPS e.max Ceram Art | 2025-12-10 IPS e.max Ceram Art Universalliquid 60ml |
| 07615208539332 - IPS e.max Ceram Art | 2025-12-10 IPS e.max Ceram Art Structure neutral 5g |
| 07615208539349 - IPS e.max Ceram Art | 2025-12-10 IPS e.max Ceram Art Structure cloud 5g |