Convex Osteotome 4.2

FDA UDI

Class I (US FDA UDI)

by Ossvis Co., Ltd.

Identity

Trade Name: Convex Osteotome 4.2 FDA UDI
Generic Name: Dental osteotome FDA UDI
Device Name: Dental Implant Surgical Instrument - Osteotome FDA UDI
Model / Reference: HSOT42 FDA UDI
Description: Dental Implant Surgical Instrument - Osteotome FDA UDI

Identifiers

Primary DI / UDI-DI: 08809918209879 FDA UDI
FDA Product Code: EMM FDA UDI
GMDN Term: Dental osteotome FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental osteotome

Convex Osteotome 4.2 by Ossvis Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Dental osteotome.

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Tatum Surgical-Osteotome — SUNCOAST DENTAL, INC. · Class I
OSTEOTOME — KLS-Martin L.P. · Class I
OSTEOTOME REPLACE - 6.0mm - RADIUS HF MARKINGS 7-10-13-16 — W.H. Holden, Inc. · Class I
KOHDENT — Kohler Medizintechnik GmbH & Co. KG · 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

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Manufacturer

Manufacturer: Ossvis Co., Ltd.

Sources (1)

FDA UDI 2e801704-40be-4280-a644-747b9ea07ff6 33 fields · synced Jun 1, 2026