AccessGUDID - DEVICE: GATES-GLIDDEN DRILLS RA, N°4 (J01020332)

GUDID

Device Identifier (DI) Information

Brand Name: GATES-GLIDDEN DRILLS RA, N°4
Version or Model: 20332
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Produits dentaires S.A.

Primary DI Number: J01020332
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480420090 *Terms of Use

Device Description: Rack of 6 - 32 mm length - Diam 1.10 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
31876	Endodontic enlarger, reusable	A manual dental instrument designed to be used to access the root canal and to enlarge the opening of the coronal portion of the root canal. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EKQ	Preparer, Root Canal Endodontic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bc428ec9-c42e-4314-aa7a-a3700b7a7e7e
Public Version Date: June 30, 2022
Public Version Number: 1
DI Record Publish Date: June 22, 2022