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: MDL Implant Single Ossean 2.5 x 18mm FDA UDI
Model / Reference: MDL2518SZ FDA UDI
Description: MDL Implant Single Ossean 2.5 x 18mm FDA UDI

Identifiers

Catalog Number: MDL2518SZ FDA UDI
Primary DI / UDI-DI: 00847236014100 FDA UDI
510(k) Number: K070601 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 3022ef49-9858-4ab4-abb3-ce42b48e5a10 35 fields · synced Jun 8, 2026