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Resin Marker

FDA UDI

Class I (US FDA UDI)

by OSSTEM IMPLANT Co., Ltd.

Identity

Trade Name
Resin Marker FDA UDI
Generic Name
Dental guided surgery registration/navigation spatial marker FDA UDI
Model / Reference
RSMRKS FDA UDI

Identifiers

Primary DI / UDI-DI
08809917100733 FDA UDI
FDA Product Code
NDP FDA UDI
GMDN Term
Dental guided surgery registration/navigation spatial marker 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 guided surgery registration/navigation spatial marker

Resin Marker by OSSTEM IMPLANT Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental guided surgery registration/navigation spatial marker.

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 d9917d48-8387-459f-92e1-f09b8a209413 32 fields · synced Jun 1, 2026