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Simple Mount

FDA UDI

Class I (US FDA UDI)

by OSSTEM IMPLANT Co., Ltd.

Identity

Trade Name
Simple Mount FDA UDI
Generic Name
Dental implant holding endpiece, reusable FDA UDI
Model / Reference
ESFMR FDA UDI

Identifiers

Primary DI / UDI-DI
08800000933344 FDA UDI
FDA Product Code
NDP FDA UDI
GMDN Term
Dental implant holding endpiece, reusable 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 holding endpiece, reusable

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

Similar devices

Also classified as Dental implant holding endpiece, reusable.

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 2261a18f-e0fe-4a22-90f9-1f054b2d45ac 32 fields · synced May 31, 2026