Tatum Surgical-Tapered Osteotome Kit

FDA UDI

Class I (US FDA UDI)

by Suncoast Dental, Inc.

Identity

Trade Name: Tatum Surgical-Tapered Osteotome Kit FDA UDI
Generic Name: Dental osteotome set FDA UDI
Device Name: Tatum Tapered Straight Osteotome Kit designed for use in bone expansion utilizing Tatum Tapered & Integrity Implants: Includes 24 instruments and 2 Autoclaveable cassettes: White - 3.0x15, 18, 21, 23, Blue - 3.5x12, 15, 18, & 21 Red - 4.0x12, 15, 18, & 21 Yellow - 4.5x12, 15, 18, & 21 Black - 5.0x12, 15, 18, & 21 Green - 6.0x12, 15, 18, & 21 FDA UDI
Model / Reference: Tatum Tapered Straight Osteotome Kit FDA UDI
Description: Tatum Tapered Straight Osteotome Kit designed for use in bone expansion utilizing Tatum Tapered & Integrity Implants: Includes 24 instruments and 2 Autoclaveable cassettes: White - 3.0x15, 18, 21, 23, Blue - 3.5x12, 15, 18, & 21 Red - 4.0x12, 15, 18, & 21 Yellow - 4.5x12, 15, 18, & 21 Black - 5.0x12, 15, 18, & 21 Green - 6.0x12, 15, 18, & 21 FDA UDI

Identifiers

Catalog Number: OsteotomeTapered Str 24 FDA UDI
Primary DI / UDI-DI: 00083208033339 FDA UDI
FDA Product Code: EMM FDA UDI
GMDN Term: Dental osteotome set 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

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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental osteotome set

Tatum Surgical-Tapered Osteotome Kit by Suncoast Dental, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 af91eebd-2311-43e7-9ad1-1c7ae1e0b55c 35 fields · synced May 30, 2026