Identity
- Trade Name
- ARCUS FDA UDI
- Generic Name
- Facebow FDA UDI
- Device Name
- This is a medical device. FDA UDI
- Model / Reference
- 0.622.5000 FDA UDI
- Description
- This is a medical device. FDA UDI
Identifiers
- Catalog Number
- NA FDA UDI
- Primary DI / UDI-DI
- EKAV062250000 FDA UDI
- FDA Product Code
- EJP FDA UDI
- GMDN Term
- Facebow FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3150 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Category: Facebow
Arcus by KaVo Dental GmbH — Class I — FDA UDI — listed in FDA GUDID — 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 (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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
- KaVo Dental GmbH
Sources (1)
- FDA UDI 7d1413d2-4384-498f-9f52-a17e3e7aa3a2 36 fields · synced Jun 8, 2026