AccessGUDID - DEVICE: Caulk® Super Bur® (D0026657201)

GUDID

Device Identifier (DI) Information

Brand Name: Caulk® Super Bur®
Version or Model: 665720
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 665720
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D0026657201
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Caulk® Super Bur® Round I Bur No. 6 - Slow Speed

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":	Yes
For Single-Use:	Yes
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?
37871	Crown surgical drill bit, reusable	A shaft of metal with a hollow centre designed for overdrilling a surgical screw or screw shaft to expose it for its removal, with another instrument, when the screw head has become defective or detached. The device is commonly called a "hollow mill" or "crown drill", but may also be referred to as a "hollow reamer", and is designed as a cylindrical hollow shell with a thin wall that has saw teeth at the cutting edge. It is inserted into a surgical power tool for rotation. This device may also be used to obtain core bone biopsies. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EJL	BUR, DENTAL

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
Device Size Text, specify: Strip of 10 Burs - Round I Bur No. 6

Device Record Status

Public Device Record Key: 8492d92a-7859-4fc8-87d5-b6098ca8460c
Public Version Date: September 01, 2022
Public Version Number: 1
DI Record Publish Date: August 24, 2022