AccessGUDID - DEVICE: Caulk® Super Bur® (D0026657741)

GUDID

Device Identifier (DI) Information

Brand Name: Caulk® Super Bur®
Version or Model: 665774
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 665774
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D0026657741
Issuing Agency: HIBCC
Commercial Distribution End Date: May 03, 2024
Device Count: 10
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Caulk Super Bur 10-Pack - Size 35 FG

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:	Yes
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?
16668	Carbide dental bur, reusable	A rotary cutting device made of high-grade steel, the working end of which is made from, or coated with, tungsten carbide, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, e.g., teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials. 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
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
Special Storage Condition, Specify: Keep devices in sterilization packaging in a dry and clean environment.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 10x Burs - Size 35 FG Super Bur

Device Record Status

Public Device Record Key: 6a1b8a9d-98f8-4764-bfab-34dbdafbf81c
Public Version Date: May 03, 2024
Public Version Number: 3
DI Record Publish Date: April 02, 2019