AccessGUDID - DEVICE: MACRO-LOCK FINISHING DRILL 3 (ERTDC060100000300000)

GUDID

Device Identifier (DI) Information

Brand Name: MACRO-LOCK FINISHING DRILL 3
Version or Model: 4520123
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4520123
Company Name: RECHERCHES TECHNIQUES DENTAIRES

Primary DI Number: ERTDC060100000300000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 260303508 *Terms of Use

Device Description: Dental drill

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?
43311	Pin/post dental drill bit	A shaft of metal, typically with a spiralled portion at the cutting end (a twist drill bit), intended to be attached to a motorized handpiece, or other power source, to create a precise round hole at the appropriate depth in teeth or bone of the oral cavity. This hole or slot is used to secure cast or preformed pins/posts for stabilizing and retaining operative dental appliances. 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: 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: 17446b4e-3924-4eec-8a59-fd04935839f1
Public Version Date: March 30, 2023
Public Version Number: 2
DI Record Publish Date: December 07, 2022