Identity
- Trade Name
- HELMUT ZEPF FDA UDI
- Generic Name
- Dental regeneration membrane fixation tack, non-bioabsorbable FDA UDI
- Device Name
- FIXATION, INTRAOSSEOUS TITANIUM PIN, 5 MM, DIAM. 2.5 MM PACKING UNIT = 5 PIECES FDA UDI
- Model / Reference
- 47.560.05 FDA UDI
- Description
- FIXATION, INTRAOSSEOUS TITANIUM PIN, 5 MM, DIAM. 2.5 MM PACKING UNIT = 5 PIECES FDA UDI
Identifiers
- Catalog Number
- 47.560.05 FDA UDI
- Primary DI / UDI-DI
- EZPF47560050 FDA UDI
- FDA Product Code
- DZL FDA UDI
- GMDN Term
- Dental regeneration membrane fixation tack, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4880 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental regeneration membrane fixation tack, non-bioabsorbable
Helmut Zepf by Helmut Zepf Medizintechnik GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental regeneration membrane fixation tack, non-bioabsorbable.
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- Neoss Implant System — Neoss, Ltd. · Class II
- GBR Screw — DENTIS CO. , LTD · 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
- Helmut Zepf Medizintechnik GmbH
Sources (1)
- FDA UDI bc970839-e320-4c4f-b9da-dcb802f82f6f 35 fields · synced Jun 8, 2026