Identity
- Trade Name
- BioHorizons FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- MDL Straight Abutment, Peek FDA UDI
- Model / Reference
- MDLSAPZ FDA UDI
- Description
- MDL Straight Abutment, Peek FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847236014681 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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional 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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Cleared under the same submission
K053099 also covers:
K080598 also covers:
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC.
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC.
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC.
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC.
- Intra-Lock — Intra-Lock International
- MDL — Intra-Lock International
- MDL — Intra-Lock International
- MDL — Intra-Lock International
- MDL — Intra-Lock International
- MDL — Intra-Lock International
K223697 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 077d0950-5724-4eba-ad1b-6a2e93eb2f4e 34 fields · synced Jun 1, 2026