Identity
- Trade Name
- OneBite Evolution FDA UDI
- Generic Name
- Facebow FDA UDI
- Device Name
- Articulator Slider Whipmix® FDA UDI
- Model / Reference
- OBEV0039 FDA UDI
- Description
- Articulator Slider Whipmix® FDA UDI
Identifiers
- Catalog Number
- OBEV0039 FDA UDI
- Primary DI / UDI-DI
- 00850031761285 FDA UDI
- FDA Product Code
- EHY FDA UDI
- GMDN Term
- Facebow FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6880 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Facebow
OneBite Evolution by Precision Dental Products, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Facebow.
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- JMA Optic USB-L — zebris MEDICAL GmbH · Class I
- Reicodent — devemed GmbH · Class I
- PlaneAnalyser II — zebris MEDICAL GmbH · Class I
- Inductive Charger zebris for ceramill — zebris MEDICAL GmbH · Class I
- JMA Optic — zebris MEDICAL GmbH · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- devemed — devemed 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
- Precision Dental Products, Llc
Sources (1)
- FDA UDI 74922158-fee1-4a6e-93ff-011e4af4c783 35 fields · synced Jun 8, 2026