AccessGUDID - DEVICE: TOFFLEMIRE MATRIX BANDS THIN N°11 (07640159162025)

GUDID

Device Identifier (DI) Information

Brand Name: TOFFLEMIRE MATRIX BANDS THIN N°11
Version or Model: 41524
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Produits dentaires S.A.

Primary DI Number: 07640159162025
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480420090 *Terms of Use

Device Description: Tofflemire matrix bands Type 8 matrix bands are stainless steel anatomically preformed bands used in combination with matrix retainers as part of contouring for restorative treatment. It enables to perform restoration with anatomic proximal contours and contact areas, by creating a temporary interproximal surface (contour). The different matrix bands provided by Produits Dentaires differ in geometry and size. All references exist in 2 different thickness: thin (0.05mm) and xthin (0.035mm). Tofflemire matrix retainers secure the appropriate matrix band in place Box of 12 bands - N°11

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):	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?
16195	Dental matrix band, reusable	A band or strip of strong material (typically stainless steel or transparent polyester) or a short tube that is used to form a mould around a tooth for the insertion of restorative materials. The device is held snugly around the tooth by a matrix retainer or tensioned around the tooth using a dedicated mechanical tensioning device. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DYO	Band, Material, Orthodontic

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: dfd25690-40ea-4635-b86e-9bf7a0c92ea9
Public Version Date: July 07, 2022
Public Version Number: 1
DI Record Publish Date: June 29, 2022