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Smartbrush 2

FDA UDI

Class I (US FDA UDI)

by OSSTEM IMPLANT Co., Ltd.

Identity

Trade Name
Smartbrush 2 FDA UDI
Generic Name
Dental implant/teeth debridement brush, non-biodegradable FDA UDI
Model / Reference
OPISB26S FDA UDI

Identifiers

Primary DI / UDI-DI
08800000981567 FDA UDI
FDA Product Code
NDP FDA UDI
GMDN Term
Dental implant/teeth debridement brush, non-biodegradable 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dental implant/teeth debridement brush, non-biodegradable

Smartbrush 2 by OSSTEM IMPLANT Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental implant/teeth debridement brush, non-biodegradable.

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 886a06eb-f51c-44d3-a7b4-09f0c697ec07 32 fields · synced May 30, 2026