Identity
- Trade Name
- FIX FDA UDI
- Generic Name
- Basket endosteal dental implant, two-piece FDA UDI
- Device Name
- GIH dental implant 4.2mm Dia length 16 mm FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- GIH dental implant 4.2mm Dia length 16 mm FDA UDI
Identifiers
- Catalog Number
- GIH-4216 FDA UDI
- Primary DI / UDI-DI
- 07290109747408 FDA UDI
- 510(k) Number
- K103280 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
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
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 16 Millimeter FDA UDIOuter Diameter — 4.2 Millimeter FDA UDI
Category: Basket endosteal dental implant, two-piece
Fix by Bhi Implants Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Basket endosteal dental implant, two-piece.
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Cleared under the same submission
K103280 also covers:
- Abutment Screw — BHI IMPLANTS LTD
- Ball Attachment — BHI IMPLANTS LTD
- Bar Abutment for 3.0 mm — BHI IMPLANTS LTD
- Bar Abutment for 3.5 mm — BHI IMPLANTS LTD
- CONHEX — BHI IMPLANTS LTD
- CONHEX — BHI IMPLANTS LTD
- CONHEX — BHI IMPLANTS LTD
- CONHEX — BHI IMPLANTS LTD
- CONHEX — BHI IMPLANTS LTD
- CONHEX — BHI IMPLANTS LTD
- CONHEX — BHI IMPLANTS LTD
- CONHEX — BHI IMPLANTS LTD
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
- Bhi Implants Ltd
Sources (1)
- FDA UDI 9314333f-4b05-4daa-91d3-cd6226eb9366 38 fields · synced Jun 1, 2026