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OneGuide Implant Anchor

FDA UDI

Class I (US FDA UDI)

by OSSTEM IMPLANT Co., Ltd.

Identity

Trade Name
OneGuide Implant Anchor FDA UDI
Generic Name
Dental implantation drilling template stabilization bolt FDA UDI
Model / Reference
OGFAKR FDA UDI

Identifiers

Primary DI / UDI-DI
08800209361658 FDA UDI
FDA Product Code
NDP FDA UDI
GMDN Term
Dental implantation drilling template stabilization bolt 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

No

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dental implantation drilling template stabilization bolt

OneGuide Implant Anchor by OSSTEM IMPLANT Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental implantation drilling template stabilization bolt.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
OSSTEM IMPLANT Co., Ltd.

Sources (1)

  • FDA UDI 6e4d1ede-2322-4712-9cd5-1166420030ce 32 fields · synced May 30, 2026