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BioHorizons

FDA UDI

Class II (US FDA UDI)

by Biohorizons Implant Systems Inc.

Identity

Trade Name
BioHorizons FDA UDI
Generic Name
Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Device Name
3.0mm Custom Temporary Abutment, 1mm Height, Laser-Lok FDA UDI
Model / Reference
TP3CTA1L FDA UDI
Description
3.0mm Custom Temporary Abutment, 1mm Height, Laser-Lok FDA UDI

Identifiers

Primary DI / UDI-DI
00847236010607 FDA UDI
510(k) Number
K093321 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
Not 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

BioHorizons by Biohorizons Implant Systems Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K093321 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biohorizons Implant Systems Inc.

Sources (1)

  • FDA UDI 36d45741-f402-4d46-a917-2d3a204c82ac 35 fields · synced Jun 6, 2026