Tatum Channel Former D2 5.5mm

FDA UDI

Class I (US FDA UDI)

by Suncoast Dental, Inc.

Identity

Trade Name: Tatum Channel Former D2 5.5mm FDA UDI
Generic Name: Dental osteotome FDA UDI
Device Name: Tatum D2 5.5 D Shaped Channel former used for creating an osteotomy for a dental implant FDA UDI
Model / Reference: D2 5.5mm Channel former FDA UDI
Description: Tatum D2 5.5 D Shaped Channel former used for creating an osteotomy for a dental implant FDA UDI

Identifiers

Catalog Number: D2 5.5 Channel Former FDA UDI
Primary DI / UDI-DI: 00083208640551 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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental osteotome

Tatum Channel Former D2 5.5mm by Suncoast Dental, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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
KANER SPREADER 7.5mm — W.H. Holden, Inc. · 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: Suncoast Dental, Inc.

Sources (1)

FDA UDI 329a21b6-8265-4ce6-baa7-33eed2384674 36 fields · synced Jun 1, 2026