Identity
- Trade Name
- LEONE SPA FDA UDI
- Generic Name
- Orthodontic face bow FDA UDI
- Device Name
- WELDABLE ADVANCEMENT BITE FDA UDI
- Model / Reference
- M3714-00 FDA UDI
- Description
- WELDABLE ADVANCEMENT BITE FDA UDI
Identifiers
- Catalog Number
- M3714-00 FDA UDI
- Primary DI / UDI-DI
- 08033707068198 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthodontic face bow
Leone Spa by Leone Spa — 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
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
- Leone Spa
Sources (1)
- FDA UDI 20d57aca-1393-444d-939d-5102750a977b 34 fields · synced Jun 8, 2026