Diastema Closure Kit

GUDID D9498020022

Convenience kit of Bioclear products used in anterior dental restorations.

Bioclear Matrix Systems

Dental matrix band kit
Primary Device IDD9498020022
NIH Device Record Key8b2f065a-ba9d-4a15-b06c-3339e5de2a7a
Commercial Distribution StatusIn Commercial Distribution
Brand NameDiastema Closure Kit
Version Model NumberMini
Company DUNS059020838
Company NameBioclear Matrix Systems
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD9498020022 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-19
Device Publish Date2023-09-11

Devices Manufactured by Bioclear Matrix Systems

D9498270912 - Evolve Matrix Procedure Kit2024-07-18 Convenience kit of Bioclear products used in posterior dental restorations.
D9495000821 - Bioclear Instrument2024-04-15 Metal instrument used in dental restorations.
D9498271312 - Select Bioclear Evolve Posterior Kit2024-04-15 Convenience kit of Bioclear products used in posterior dental restorations.
D9498271412 - Bioclear Evolve Posterior Kit2024-04-15 Convenience kit of Bioclear products used in posterior dental restorations.
D949208011R1 - Bioclear TwinRing2023-09-25 Separator ring used in dental restorations.
D949208021R1 - Bioclear TwinRing2023-09-25 Separator ring used in dental restorations.
D9492080311 - Bioclear TwinRing Molar/Premolar Pack2023-09-25 Separator ring used in dental restorations.
D949208031K1 - Bioclear TwinRing Molar/Premolar Pack2023-09-25 Separator ring used in dental restorations.

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.