BioHorizons

FDA UDI

Class I (US FDA UDI)

by Biohorizons Implant Systems Inc.

Identity

Trade Name: BioHorizons FDA UDI
Generic Name: Resilient dental precision attachment FDA UDI
Device Name: MDL/MILO Metal Housing w/ O-Ring FDA UDI
Model / Reference: MDLMHZ FDA UDI
Description: MDL/MILO Metal Housing w/ O-Ring FDA UDI

Identifiers

Primary DI / UDI-DI: 00847236017279 FDA UDI
FDA Product Code: NDP FDA UDI
GMDN Term: Resilient dental precision 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Resilient dental precision attachment

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

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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 I	Pending data

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Manufacturer

Manufacturer: Biohorizons Implant Systems Inc.

Sources (1)

FDA UDI 4bdf7f55-1ce9-42ae-bd79-8cbc7775988d 33 fields · synced May 30, 2026