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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 instrument depth limiter FDA UDI
Device Name
CGS Disposable Depth Stop FDA UDI
Model / Reference
CGS-DDS FDA UDI
Description
CGS Disposable Depth Stop FDA UDI

Identifiers

Primary DI / UDI-DI
00847236001278 FDA UDI
FDA Product Code
NDP FDA UDI
GMDN Term
Dental instrument depth limiter 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

Yes

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 instrument depth limiter

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

Similar devices

Also classified as Dental instrument depth limiter.

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 4f3ccd5f-acb6-4473-94a5-555f23f875a0 33 fields · synced Jun 7, 2026