AccessGUDID - DEVICE: CTT CERAMIC TISSUE TRIMMER (05713513000157)

GUDID

Device Identifier (DI) Information

Brand Name: CTT CERAMIC TISSUE TRIMMER
Version or Model: 24017
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Rønvig Dental Manufacturing A/S

Primary DI Number: 05713513000157
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 307549241 *Terms of Use

Device Description: A rotating instrument used for minor surgical procedures in dentistry.

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):	Yes
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?
63630	Ceramic dental bur	A rotary cutting device, the working end of which is made from ceramic, designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth and bone. It is available in various shapes (e.g., cylinder, disk, sphere, oval). 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: dc56e7cf-278f-40d7-a3c0-f064d515f0e9
Public Version Date: October 06, 2022
Public Version Number: 1
DI Record Publish Date: September 28, 2022