Osstem Implant Co., Ltd. Chair Business

FDA UDI

Class I (US FDA UDI)

by OSSTEM IMPLANT Co., Ltd.

Identity

Trade Name: OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS FDA UDI
Generic Name: Dental delivery system FDA UDI
Device Name: The K5 is intended to supply power to and serve as a base for dental devices and accessories.This product is intended for use by dentist and dental assistance to assist dental treatment of patients for adjusting the position of the patient seat, operating the instruments, and suppling water into the oral cavity through a water line in dental clinical environments. FDA UDI
Model / Reference: K5 FDA UDI
Description: The K5 is intended to supply power to and serve as a base for dental devices and accessories.This product is intended for use by dentist and dental assistance to assist dental treatment of patients for adjusting the position of the patient seat, operating the instruments, and suppling water into the oral cavity through a water line in dental clinical environments. FDA UDI

Identifiers

Primary DI / UDI-DI: 08800000996264 FDA UDI
510(k) Number: K251491 FDA UDI
FDA Product Code: EIA FDA UDI
KLC FDA UDI
GMDN Term: Dental delivery system FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.6640 FDA UDI
872.6250 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental delivery system

Osstem Implant Co., Ltd. Chair Business by OSSTEM IMPLANT Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental delivery system.

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V8 TOUCH — VITALI S.R.L. · Class IIa
Forest — Ls Enterprises, Inc. · Class I
Forest — Ls Enterprises, Inc. · Class I
TY-830 — Foshan Toye Dental Equipment Co., Ltd · Class I
Forest — Ls Enterprises, Inc. · Class I
A5 SINGLE CART — CEFLA s.c. · Class IIa
Forest — Ls Enterprises, Inc. · Class I

Cleared under the same submission

K251491 also covers:

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

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Manufacturer

Manufacturer: OSSTEM IMPLANT Co., Ltd.

Sources (1)

FDA UDI 2626ba49-6da9-498f-98b2-1b280302a432 34 fields · synced May 30, 2026