BioHorizons

FDA UDI

Class II (US FDA UDI)

by Biohorizons Implant Systems Inc.

Identity

Trade Name: BioHorizons FDA UDI
Generic Name: Screw endosteal dental implant, two-piece FDA UDI
Device Name: 4.6mm x 12mm Tapered Pro Implant, Laser-Lok, RBT FDA UDI
Model / Reference: BTA4612 FDA UDI
Description: 4.6mm x 12mm Tapered Pro Implant, Laser-Lok, RBT FDA UDI

Identifiers

Primary DI / UDI-DI: 00847236013776 FDA UDI
510(k) Number: K071638 FDA UDI
K143022 FDA UDI
K223697 FDA UDI
FDA Product Code: DZE FDA UDI
GMDN Term: Screw endosteal dental implant, two-piece FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3640 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Screw endosteal dental implant, two-piece

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

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 6f41cb47-f7d9-45f1-8216-b8f3baa5a8cf 34 fields · synced Jun 6, 2026