Identity
- Trade Name
- Full Form Extraoral Facebow FDA UDI
- Generic Name
- Orthodontic face bow FDA UDI
- Device Name
- Extraoral Facebow Universal Standard FDA UDI
- Model / Reference
- 551-210 FDA UDI
- Description
- Extraoral Facebow Universal Standard FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190730004581 FDA UDI
- 510(k) Number
- K980195 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
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
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
Full Form Extraoral Facebow by Ortho Technology, 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
- ODP FACEBOW — G&H Wire Company, 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
Cleared under the same submission
K980195 also covers:
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Full Form Extraoral Facebow — ORTHO TECHNOLOGY, INC.
- Full Form Extraoral Facebow — ORTHO TECHNOLOGY, INC.
- Full Form Extraoral Facebow — ORTHO TECHNOLOGY, INC.
- Full Form Extraoral Facebow — ORTHO TECHNOLOGY, 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 |
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Manufacturer
- Manufacturer
- Ortho Technology, Inc.
Sources (1)
- FDA UDI 3cb2fdc2-161d-4e2f-b2f1-0c88722b71fc 34 fields · synced Jun 6, 2026