Identity
- Trade Name
- Ponto FDA UDI
- Generic Name
- Craniofacial bone screw, non-bioabsorbable FDA UDI
- Device Name
- Ponto BHX Implant, 4 mm, with abutment, 6mm FDA UDI
- Model / Reference
- M52168 FDA UDI
- Description
- Ponto BHX Implant, 4 mm, with abutment, 6mm FDA UDI
Identifiers
- Catalog Number
- M52168 FDA UDI
- Primary DI / UDI-DI
- 05712149009602 FDA UDI
- FDA Product Code
- MAH FDA UDI
- GMDN Term
- Craniofacial bone screw, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3302 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 4 Millimeter FDA UDIOuter Diameter — 4.5 Millimeter FDA UDILength — 6 Millimeter FDA UDI
Category: Craniofacial bone screw, non-bioabsorbable
Ponto by Oticon Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Craniofacial bone screw, non-bioabsorbable.
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- Leforte System Bone Screw / GBR System Bone Screw — Jeil Medical 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
- Oticon Medical
Sources (1)
- FDA UDI ebaf0dd2-517f-480a-8f10-e3ee6eea536d 36 fields · synced May 30, 2026