AccessGUDID - DEVICE: Paraband Tofflemire Matrix Bands (00723896011065)

GUDID

Device Identifier (DI) Information

Brand Name: Paraband Tofflemire Matrix Bands
Version or Model: 7128310
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 71-28310
Company Name: PRACTICON, INC.

Primary DI Number: 00723896011065
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 119193803 *Terms of Use

Device Description: Paraband Tofflemire Matrix Bands save time and improve the quality of restorations with their more conical formation. Direct Class II composites are simpler and faster to set up, often with no wedges or separating springs required. Restore teeth in a neutral, stable position with predictable broad and deep contacts. Large MODs will become routine. For direct Class III, IV and V composites, the band provides better isolation of the prep, as well as a stable matrix for condensing composite. Bonding to subgingival preparations is simpler due to the isolation and access provided. Works with any Tofflemire retainer. Precision-cut 0.0015" thin stainless steel.

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?
38786	Dental matrix band, single-use	A band or strip of strong material (typically a transparent plastic) or a short tube that is used to form a mould around a tooth for the insertion of restorative materials. The device is typically held snugly around the tooth by a matrix retainer. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JEP	Retainer, Matrix

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: 1704d9c8-dc04-4498-ab62-f4e93bde5876
Public Version Date: August 20, 2018
Public Version Number: 1
DI Record Publish Date: July 19, 2018