ZA-55 Scaler

GUDID J021100355010

ZA-55 Scaler without light

W & H Dentalwerk Bürmoos GmbH

Pneumatic dental scaling/debridement system
Primary Device IDJ021100355010
NIH Device Record Keya4a5747d-b6bd-4da7-a53b-04432eded9b4
Commercial Distribution Discontinuation2024-08-07
Commercial Distribution StatusNot in Commercial Distribution
Brand NameZA-55 Scaler
Version Model Number10035501
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
HIBCCJ021100355010 [Direct Marking]
HIBCCJ021100355011 [Primary]

FDA Product Code

EFBHandpiece, Air-Powered, Dental

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[J021100355010]

Moist Heat or Steam Sterilization


[J021100355010]

Moist Heat or Steam Sterilization


[J021100355010]

Moist Heat or Steam Sterilization


[J021100355010]

Moist Heat or Steam Sterilization


[J021100355010]

Moist Heat or Steam Sterilization


[J021100355010]

Moist Heat or Steam Sterilization


[J021100355010]

Moist Heat or Steam Sterilization


[J021100355010]

Moist Heat or Steam Sterilization


[J021100355010]

Moist Heat or Steam Sterilization


[J021100355010]

Moist Heat or Steam Sterilization


[J021100355010]

Moist Heat or Steam Sterilization


[J021100355010]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-08-08
Device Publish Date2018-08-31

Devices Manufactured by W & H Dentalwerk Bürmoos GmbH

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
J021305030051 - Piezomed Pro Accessory2025-09-30 Instrument MR5-S
J021305030061 - Piezomed Pro Accessory2025-09-30 Instrument MR6-S
J021305030071 - Piezomed Pro Accessory2025-09-30 Instrument MS1-S

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.