FDA.reportPublic FDA data

PROXEO Twist Cordless Polishing System PL-40 H

Primary DI
J021303170000
Brand
PROXEO Twist Cordless Polishing System PL-40 H
Company
W & H Dentalwerk Bürmoos GmbH
Model
30317000
Device description
Drive Handpiece
Published
2021-06-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
EKXHandpiece, Direct Drive, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKXHandpiece, Direct Drive, Ac-PoweredDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J021303170000Direct MarkingHIBCC0
J021303170001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental-professional prophylaxis brush, reusableA rotary dental instrument with natural or synthetic bristle brushes intended to be used by a dental hygienist and/or dentist to clean and polish teeth. It is designed to be attached to a powered dental handpiece which provides the necessary rotation. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
300238441
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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J021305070001Piezomed Module Plus II (SP-210 M)305070002026-06-23
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J021301040001AM-25 A BC Air Motor301040002023-07-11
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J021078122001Tip Set: 1E, 2E, 3E, 4E, 5E, 6E078122002023-08-14
J021058492011Scaler Tip 4U058492012023-07-19

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