Identity
- Trade Name
- ODP FACEBOW FDA UDI
- Generic Name
- Orthodontic face bow FDA UDI
- Device Name
- FACEBOW GREEN 104mm FDA UDI
- Model / Reference
- M500-104 FDA UDI
- Description
- FACEBOW GREEN 104mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10190886000076 FDA UDI
- 510(k) Number
- K111169 FDA UDI
- FDA Product Code
- DZB FDA UDI
- GMDN Term
- Orthodontic face bow FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.5500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthodontic face bow
Odp Facebow by G&H Wire Company, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic face bow.
- Henry Schein — HENRY SCHEIN, INC. · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class II
- Facebow — Ormco Corporation · Class II
- Masel — Ortho Organizers, Inc. · Class II
- Facebow — Ormco Corporation · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class II
- Facebow — Ormco Corporation · Class II
- Facebow — Ormco Corporation · Class II
Cleared under the same submission
K111169 also covers:
- G&H COLOR COATED FACEBOW — G&H Wire Company, Inc.
- G&H COLOR COATED FACEBOW — G&H Wire Company, Inc.
- G&H HIGH PULL HEADCAP — G&H Wire Company, Inc.
- G&H HIGH PULL HEADCAP — G&H Wire Company, Inc.
- G&H PROTRACTION FACE MASK, CHIN CUP — G&H Wire Company, Inc.
- G&H PROTRACTION FACE MASK, PADS — G&H Wire Company, Inc.
- G&H REVERSE PULL FACE MASK, CHIN & FOREHEAD PADS — G&H Wire Company, Inc.
- G&H REVERSE PULL FACE MASK, LARGE — G&H Wire Company, Inc.
- G&H REVERSE PULL FACE MASK, SCREWS — G&H Wire Company, Inc.
- G&H STANDARD FACEBOW — G&H Wire Company, Inc.
- G&H STANDARD FACEBOW — G&H Wire Company, Inc.
- G&H STANDARD FACEBOW — G&H Wire Company, Inc.
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- G&H Wire Company, Inc.
Sources (1)
- FDA UDI a03ac69b-5ac9-4792-8443-d77edd6d7810 35 fields · synced Jun 8, 2026