Genius Variable Operating System

FDA UDI

Class I (US FDA UDI)

by Ultradent Products, Inc.

Identity

Trade Name: Genius Variable Operating System FDA UDI
Generic Name: Dental laboratory drilling system motor FDA UDI
Device Name: Genius 8:1 Contra-Angle Kit FDA UDI
Model / Reference: 4056 FDA UDI
Description: Genius 8:1 Contra-Angle Kit FDA UDI

Identifiers

Catalog Number: 4056 FDA UDI
Primary DI / UDI-DI: 00883205101648 FDA UDI
510(k) Number: K052741 FDA UDI
FDA Product Code: EBW FDA UDI
GMDN Term: Dental laboratory drilling system motor FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4200 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

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 laboratory drilling system motor

Genius Variable Operating System by Ultradent Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Endo-Eze AET Contra Angle — ULTRADENT PRODUCTS, 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: Ultradent Products, Inc.

Sources (1)

FDA UDI 6389de13-2c13-4a86-9d4f-8b72c4a080e3 36 fields · synced Jun 8, 2026