Gates-Glidden Drills Ra, N°3

FDA UDI

Class I (US FDA UDI)

by Produits dentaires S.A.

Identity

Trade Name: GATES-GLIDDEN DRILLS RA, N°3 FDA UDI
Generic Name: Endodontic enlarger, reusable FDA UDI
Device Name: Rack of 6 - 32 mm length - Diam 0.90 Gates Glidden are mechanized dental instruments used for accessing to the root canal and enlarging the opening of the coronal part of the root canal, before and after using files. Gates-Glidden are also used for pin or post hole preparation. FDA UDI
Model / Reference: 20322 FDA UDI
Description: Rack of 6 - 32 mm length - Diam 0.90 Gates Glidden are mechanized dental instruments used for accessing to the root canal and enlarging the opening of the coronal part of the root canal, before and after using files. Gates-Glidden are also used for pin or post hole preparation. FDA UDI

Identifiers

Primary DI / UDI-DI: J01020322 FDA UDI
FDA Product Code: EKQ FDA UDI
GMDN Term: Endodontic enlarger, reusable 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: Endodontic enlarger, reusable

Gates-Glidden Drills Ra, N°3 by Produits dentaires S.A. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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rootEX set 1, 3 mm, pu: 1 drill 1, 3 mm, — Diaswiss SA · Class I
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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: Produits dentaires S.A.

Sources (1)

FDA UDI 6abfc379-ad2a-40ed-9863-83386e03ee01 34 fields · synced May 31, 2026