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BioHorizons

FDA UDI

Class I (US FDA UDI)

by Biohorizons Implant Systems Inc.

Identity

Trade Name
BioHorizons FDA UDI
Generic Name
Dental drilling system attachment FDA UDI
Device Name
Hex Adapter, Abutment for Screw FDA UDI
Model / Reference
PXHA FDA UDI
Description
Hex Adapter, Abutment for Screw FDA UDI

Identifiers

Primary DI / UDI-DI
00847236004354 FDA UDI
FDA Product Code
NDP FDA UDI
GMDN Term
Dental drilling system attachment FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.3980 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dental drilling system attachment

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

Similar devices

Also classified as Dental drilling system attachment.

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 ba6e0070-856e-48af-854c-62d191ea9942 33 fields · synced May 30, 2026