OsstemGuide TS Mount

FDA UDI

Class I (US FDA UDI)

by OSSTEM IMPLANT Co., Ltd.

Identity

Trade Name: OsstemGuide TS Mount FDA UDI
Generic Name: Dental power tool endpiece inserter/remover FDA UDI
Model / Reference: QGHGMR FDA UDI

Identifiers

Primary DI / UDI-DI: 08809892364571 FDA UDI
FDA Product Code: NDP FDA UDI
GMDN Term: Dental power tool endpiece inserter/remover 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental power tool endpiece inserter/remover

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

Similar devices

Also classified as Dental power tool endpiece inserter/remover.

Johnson-Promident — Young Innovations, Inc. · Class I
Johnson-Promident — Young Innovations, Inc. · Class I
Johnson-Promident — Young Innovations, Inc. · Class I
SA MOUNT — OSSTEM IMPLANT Co., Ltd. · Class I
TS SNAP ON MOUNT — OSSTEM IMPLANT Co., Ltd. · Class I
TS Simple Mount(SA) — OSSTEM IMPLANT Co., Ltd. · Class I
Simple Mount — OSSTEM IMPLANT Co., Ltd. · Class I
Simple Mount — OSSTEM IMPLANT Co., Ltd. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: OSSTEM IMPLANT Co., Ltd.

Sources (1)

FDA UDI 0c0d7f84-664f-45b4-a95d-1b07b4a3c07d 32 fields · synced Jun 1, 2026