Identity
- Trade Name
- Fixation Implant Pack FDA UDI
- Generic Name
- Basket endosteal dental implant, two-piece FDA UDI
- Device Name
- Ø3.0mm x L11.5mm, Conical Connection, Narrow Platform with Cover Screw & Mount FDA UDI
- Model / Reference
- PFNC3011 FDA UDI
- Description
- Ø3.0mm x L11.5mm, Conical Connection, Narrow Platform with Cover Screw & Mount FDA UDI
Identifiers
- Primary DI / UDI-DI
- D824PFNC30110 FDA UDI
- 510(k) Number
- K152555 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Basket endosteal dental implant, two-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 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
Yes
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
No
FDA UDI
Category: Basket endosteal dental implant, two-piece
Fixation Implant Pack by Surgikor, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K152555 also covers:
- 15˚ Angled Anatomic Abutment — Surgikor, LLC
- 15˚ Angled Non-Shouldered Abutment — Surgikor, LLC
- 15˚ Angled Non-Shouldered Abutment — Surgikor, LLC
- 15˚ Angled Non-Shouldered Abutment — Surgikor, LLC
- 25˚ Angled Anatomic Abutment — Surgikor, LLC
- 25˚ Angled Non-Shouldered Abutment — Surgikor, LLC
- 25˚ Angled Non-Shouldered Abutment — Surgikor, LLC
- 25˚ Angled Non-Shouldered Abutment — Surgikor, LLC
- 25˚ Angled Non-Shouldered Abutment - Narrow Emergence — Surgikor, LLC
- Abutment short screw — Surgikor, LLC
- Anatomic Straight Abutment – Wide Emergence — Surgikor, LLC
- Anatomic Straight Abutment – Wide Emergence — Surgikor, LLC
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
- Surgikor, LLC
Sources (1)
- FDA UDI 6a9f3b08-bcc4-4705-ab92-97c5d3fd1839 34 fields · synced Jun 8, 2026