AccessGUDID - DEVICE: Original Posterior Matrix B Series (D94930301125C1)

GUDID

Device Identifier (DI) Information

Brand Name: Original Posterior Matrix B Series
Version or Model: B301 Clear
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Bioclear Matrix Systems

Primary DI Number: D94930301125C1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 059020838 *Terms of Use

Device Description: Clear matrix used in dental restorations.

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: 61fa8d89-77ad-47e3-af34-fef10fb7b6d6
Public Version Date: September 19, 2023
Public Version Number: 1
DI Record Publish Date: September 11, 2023