Cullum Osteotome Kit

FDA UDI

Class I (US FDA UDI)

by W.H. Holden, Inc.

Identity

Trade Name: CULLUM OSTEOTOME KIT FDA UDI
Generic Name: Dental osteotome FDA UDI
Model / Reference: 83-7121H FDA UDI

Identifiers

Primary DI / UDI-DI: D928837121H0 FDA UDI
FDA Product Code: GFI FDA UDI
GMDN Term: Dental osteotome FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

Cullum Osteotome Kit by W.H. Holden, Inc. — 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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Avalign — AVALIGN TECHNOLOGIES, Inc. · Class I
Tatum Surgical-Osteotome — SUNCOAST DENTAL, INC. · Class I
OSTEOTOME — KLS-Martin L.P. · Class I
KOHDENT — Kohler Medizintechnik GmbH & Co. KG · Class I
Quinelato — Schobell Industrial Ltda · Class I
Osteotome — POINTIMPLANT 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

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Manufacturer

Manufacturer: W.H. Holden, Inc.

Sources (1)

FDA UDI dcfe5f87-42dc-4e3e-aadb-b5fa7710c345 32 fields · synced May 30, 2026