Identity
- Trade Name
- BioHorizons FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Micro-Lok 3.45 x 4mm Straight Profile Healing Head FDA UDI
- Model / Reference
- 10034 FDA UDI
- Description
- Micro-Lok 3.45 x 4mm Straight Profile Healing Head FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847236002954 FDA UDI
- 510(k) Number
- K081818 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use 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
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
Yes
FDA UDI
Category: Dental implant suprastructure, temporary, preformed, single-use
BioHorizons by Biohorizons Implant Systems Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental implant suprastructure, temporary, preformed, single-use.
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Cleared under the same submission
K081818 also covers:
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC.
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC.
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC.
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC.
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC.
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC.
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC.
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC.
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC.
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC.
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC.
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC.
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
- Biohorizons Implant Systems Inc.
Sources (1)
- FDA UDI 30c53df9-c3e7-4071-a1b6-af90ca290d40 34 fields · synced May 30, 2026