AccessGUDID - DEVICE: EXPRESS LINE DIAMOND (D690SW635190XF2)

GUDID

Device Identifier (DI) Information

Brand Name: EXPRESS LINE DIAMOND
Version or Model: U-SW635-190XF
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SW635190XF
Company Name: Ss White Burs, Inc.

Primary DI Number: D690SW635190XF2
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 151760014 *Terms of Use

Device Description: Express Line Diamond Disc SuperFlex Double Sided HP 635 190XF 1 PACK

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):	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?
34816	Dental laboratory bur	A rotary cutting device made of high-grade steel, the working end of which is made from, or coated with, a hard material (e.g., particles of diamond or tungsten carbide), and which is designed to fit into a dental laboratory handpiece that provides the rotation and that is intended for dental laboratory use only to cut hard structures (e.g., metals, plastics, porcelains), during the fabrication of dental restorations. 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
DZP	INSTRUMENT, DIAMOND, 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
No Device Sizes

Device Record Status

Public Device Record Key: 714b3dac-1079-497a-89a2-ed6250a407b5
Public Version Date: May 09, 2025
Public Version Number: 2
DI Record Publish Date: February 19, 2025