FDA.report

Piezomed Pro Accessory

Primary DI
J021305030211
Brand
Piezomed Pro Accessory
Company
W & H Dentalwerk Bürmoos GmbH
Model
30503021
Device description
Instrument MS10L-S
Published
2025-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

Product Code Classifications

CodeDeviceSpecialtyClass
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
J021305030211PrimaryHIBCC0

GMDN Terms

TermDefinition
Hard/soft-tissue ultrasonic surgical systemAn assembly of devices designed to use ultrasonic energy to mechanically fragment and cut bone and soft tissue, and possibly bone cement during an orthopaedic surgical procedure (e.g., arthroplasty revision, spinal surgery); some types may in addition be intended for dental/craniomaxillofacial applications (e.g., reconstructive/plastic surgery) however none are dedicated exclusively to dental applications. It typically includes an ultrasonic energy-producing generator, a handpiece with cutting tip(s)/probe(s) to apply the energy and remove (aspirate) material, and connecting cables.

Sterilization Methods

Method

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
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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J021305030001Piezomed Pro Accessory305030002025-09-22
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J021305030021Piezomed Pro Accessory305030022025-09-22
J021305030031Piezomed Pro Accessory305030032025-09-22
J021305030041Piezomed Pro Accessory305030042025-09-22
J021305030051Piezomed Pro Accessory305030052025-09-22
J021305030061Piezomed Pro Accessory305030062025-09-22
J021305030071Piezomed Pro Accessory305030072025-09-22
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J021305030091Piezomed Pro Accessory305030092025-09-22
J021305030101Piezomed Pro Accessory305030102025-09-22
J021305030111Piezomed Pro Accessory305030112025-09-22
J021305030121Piezomed Pro Accessory305030122025-09-22
J021305030131Piezomed Pro Accessory305030132025-09-22
J021305030141Piezomed Pro Accessory305030142025-09-22
J021305030151Piezomed Pro Accessory305030152025-09-22

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00199150001989MR8MEDTRONIC POWERED SURGICAL SOLUTIONSERL2026-03-09
00763000892951M4MEDTRONIC XOMED, INC.ERL2026-02-28
J021305030001Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030011Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030021Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030031Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030041Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030051Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030061Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030071Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030081Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030091Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030101Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030111Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030121Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030131Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030141Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030151Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030161Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030171Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030181Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030191Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030201Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030221Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030231Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030241Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
00763000722401MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSERL2025-07-21
J021305000000Piezomed Pro M-PM100W & H Dentalwerk Bürmoos GmbHERL2025-07-08
J021305010000Piezomed Pro M-PH350W & H Dentalwerk Bürmoos GmbHERL2025-07-08
J021305020001Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-07-08