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SMARTbuilder System

FDA UDI

Class II (US FDA UDI)

by OSSTEM IMPLANT Co., Ltd.

Identity

Trade Name
SMARTbuilder System FDA UDI
Generic Name
Dental/maxillofacial surgical mesh, metal FDA UDI
Model / Reference
SM3W12127SB FDA UDI

Identifiers

Primary DI / UDI-DI
08800000921037 FDA UDI
510(k) Number
K120951 FDA UDI
FDA Product Code
JEY FDA UDI
GMDN Term
Dental/maxillofacial surgical mesh, metal FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.4760 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

No

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental/maxillofacial surgical mesh, metal

SMARTbuilder System by OSSTEM IMPLANT Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental/maxillofacial surgical mesh, metal.

Cleared under the same submission

K120951 also covers:

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 82eedbc8-6af5-42fb-9775-0909e243c7d7 33 fields · synced Jun 8, 2026