Identity
- Trade Name
- Osseofuse HexaPLUS Sinus Dental Implant FDA UDI
- Generic Name
- Dental implant abutment analog, laboratory FDA UDI
- Model / Reference
- HGCA-NH FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810044841145 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant abutment analog, laboratory 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
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
No
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 implant abutment analog, laboratory
Osseofuse HexaPLUS Sinus Dental Implant: A high-performance, single-use dental implant designed for precise placement and excellent osseointegration. With its unique hexagonal shape and advanced sterilization method, this implant offers unparalleled durability and minimal discomfort.
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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
- Osseofuse International Inc.
Sources (1)
- FDA UDI 5633451c-22f6-468e-83cd-f6413f40fc5b 32 fields · synced Jul 21, 2026