Identity
- Trade Name
- Gnathometer CAD (ID) EUDAMEDGnathometer M/ Gnathometer CAD FDA UDI
- Generic Name
- Facebow FDA UDI
- Device Name
- Gnathometer M/ Gnathometer CAD EUDAMEDGnathometer CAD (ID) FDA UDI
- Model / Reference
- 687679 EUDAMEDFDA UDI
- Description
- Gnathometer CAD (ID) FDA UDI
Identifiers
- Catalog Number
- 687679 FDA UDI
- Primary DI / UDI-DI
- 07615208459586 EUDAMEDFDA UDI
- Basic UDI-DI
- 76152081XBITE002WD EUDAMED
- FDA Product Code
- KZO FDA UDI
- EMDN Code
- Q010280 PROSTHETIC DENTISTRY DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Facebow FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3150 FDA UDI
- Market of Registration
- Liechtenstein EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Facebow
Gnathometer M/ Gnathometer CAD by Ivoclar Vivadent Aktiengesellschaft — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Facebow.
- OneBite Evolution — PRECISION DENTAL PRODUCTS, LLC · Class I
- OneBite Evolution — PRECISION DENTAL PRODUCTS, LLC · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- JMA Optic USB-L — zebris MEDICAL GmbH · Class I
- OneBite Evolution — PRECISION DENTAL PRODUCTS, LLC · Class I
- OneBite Evolution — PRECISION DENTAL PRODUCTS, LLC · Class I
- Reicodent — devemed GmbH · Class I
- PlaneAnalyser II — zebris MEDICAL GmbH · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ivoclar Vivadent Aktiengesellschaft
Sources (2)
- FDA UDI ae18a146-6178-4b86-b7a4-546b87d8dedb 34 fields · synced Jul 9, 2026
- EUDAMED 94165e25-1b2d-4a62-9b3c-499ee15f87f3 61 fields · synced Jul 9, 2026