AccessGUDID - DEVICE: Drill-A-Post - N°2 (07640159163367)

GUDID

Device Identifier (DI) Information

Brand Name: Drill-A-Post - N°2
Version or Model: 22512
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Produits dentaires S.A.

Primary DI Number: 07640159163367
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480420090 *Terms of Use

Device Description: DRILL-A-POST is a tapered reamer system developed for drilling posts chamber corresponding to FIBRAPOST LUX and FIBRAPOST PLUS. These stainless steel reamers are supplied with silicone rings to adjust the drilling depth.

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):	No
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
DZA	Drill, Dental, Intraoral

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: No

Sterilization Method [?]
No Sterilization Methods Found

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: 75d9f19c-deaf-473a-99d2-80b18c08469f
Public Version Date: June 01, 2023
Public Version Number: 1
DI Record Publish Date: May 24, 2023