Identity
- Trade Name
- NBB External Hex FDA UDI
- Generic Name
- Basket endosteal dental implant, two-piece FDA UDI
- Device Name
- Multi-unit Dental Implant Abutment FDA UDI
- Model / Reference
- 3.5 Multi-unit Abutment FDA UDI
- Description
- Multi-unit Dental Implant Abutment FDA UDI
Identifiers
- Catalog Number
- HE35803 FDA UDI
- Primary DI / UDI-DI
- D985HE358030 FDA UDI
- 510(k) Number
- K915375 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Basket endosteal dental implant, two-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Basket endosteal dental implant, two-piece
NBB External Hex by Fusion Dental Implants Llc — 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
K915375 also covers:
- NBB External Hex — FUSION DENTAL IMPLANTS LLC
- NBB External Hex — FUSION DENTAL IMPLANTS LLC
- NBB External Hex — FUSION DENTAL IMPLANTS LLC
- NBB External Hex — FUSION DENTAL IMPLANTS LLC
- NBB External Hex — FUSION DENTAL IMPLANTS LLC
- NBB External Hex — FUSION DENTAL IMPLANTS LLC
- NBB External Hex — FUSION DENTAL IMPLANTS LLC
- NBB External Hex — FUSION DENTAL IMPLANTS LLC
- NBB External Hex — FUSION DENTAL IMPLANTS LLC
- NBB External Hex — FUSION DENTAL IMPLANTS LLC
- NBB External Hex — FUSION DENTAL IMPLANTS LLC
- NBB External Hex — FUSION DENTAL IMPLANTS 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
- Fusion Dental Implants Llc
Sources (1)
- FDA UDI e5a49fc5-f7d5-4303-b76d-ae8c3c9b52e3 35 fields · synced May 31, 2026