AccessGUDID - DEVICE: DIAMOND ABRASIVE STRIPS, 4 mm FINE, 1S, perforated (J01046051)

GUDID

Device Identifier (DI) Information

Brand Name: DIAMOND ABRASIVE STRIPS, 4 mm FINE, 1S, perforated
Version or Model: 46051
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Produits dentaires S.A.

Primary DI Number: J01046051
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480420090 *Terms of Use

Device Description: Abrasive strips are used during restorative treatments to adjust / shape / smooth / reduce the interproximal area & contact points of the tooth‘s crown (artificial or natural). The abrasive strips are made of stainless-steel base coated with abrasive grit (corundum or diamond). The products are used in the dentistry field. Pack of 10 pcs

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?
35702	Dental abrasive strip, single-use	A manual dental device in the form of a strip coated with abrasive particles on one or both sides intended to be used for modifying the surface of a tooth or restoration during a dental procedure. It is commonly known as a polishing strip. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EHM	Strip, Polishing Agent

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: d5c30838-1dcc-47f1-a57f-532830f415b9
Public Version Date: July 07, 2022
Public Version Number: 1
DI Record Publish Date: June 29, 2022