MCA-QC-ISO

GUDID J021064226001

Assistina Adapter Quick ISO

W & H Dentalwerk Bürmoos GmbH

Surgical power tool maintenance adaptor
Primary Device IDJ021064226001
NIH Device Record Key1c2f90a5-cf8a-4a13-b45a-36407614af46
Commercial Distribution StatusIn Commercial Distribution
Brand NameMCA-QC-ISO
Version Model Number06422600
Company DUNS300238441
Company NameW & H Dentalwerk Bürmoos GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCJ021064226001 [Primary]

FDA Product Code

EFBHandpiece, Air-Powered, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-10
Device Publish Date2025-12-02

Devices Manufactured by W & H Dentalwerk Bürmoos GmbH

J021020835000 - MCA-RM-BC2025-12-10 Assistina Adapter Borden
J021063951001 - MCA-QC-RM2025-12-10 Assistina Adapter Quick RM
J021064226001 - MCA-QC-ISO2025-12-10Assistina Adapter Quick ISO
J021064226001 - MCA-QC-ISO2025-12-10 Assistina Adapter Quick ISO
J021305030001 - Piezomed Pro Accessory2025-09-30 Instrument MP1-S
J021305030011 - Piezomed Pro Accessory2025-09-30 Instrument MR1-S
J021305030021 - Piezomed Pro Accessory2025-09-30 Instrument MR2-S
J021305030031 - Piezomed Pro Accessory2025-09-30 Instrument MR3-S
J021305030041 - Piezomed Pro Accessory2025-09-30 Instrument MR4-S

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