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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 implant kit FDA UDI
Device Name
Stabili-Teeth Convenience Pack FDA UDI
Model / Reference
STCP FDA UDI
Description
Stabili-Teeth Convenience Pack FDA UDI

Identifiers

Primary DI / UDI-DI
00847236018450 FDA UDI
FDA Product Code
NDP FDA UDI
DZE FDA UDI
NHA FDA UDI
GMDN Term
Dental implant kit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.3980 FDA UDI
872.3640 FDA UDI
872.3630 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Yes

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

Category: Dental implant kit

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

Similar devices

Also classified as Dental implant kit.

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 8a678aae-c128-48b5-a07c-d6160cd9bb23 33 fields · synced May 30, 2026