FDA.reportPublic FDA data

Piezomed Pro Accessory

Primary DI
J021305030111
Brand
Piezomed Pro Accessory
Company
W & H Dentalwerk Bürmoos GmbH
Model
30503011
Device description
Instrument MS3R-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
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZIDrill, Bone, Powered
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
JDXInstrument, Surgical, Sonic And Accessory/Attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZIDrill, Bone, PoweredDental2
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceEar, Nose, Throat2
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1
JDXInstrument, Surgical, Sonic And Accessory/AttachmentOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J021305030111PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
300238441
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
J021100355321ZA-55 Scaler B.F. A-dec100355322016-09-19
J021301790001EA-53 electric motor (A-dec)301790002023-07-11
J021304950011Foot control S-NW3304950012026-06-23
J021304970001Foot control S-N3304970002026-06-23
J021305040001Implantmed Plus II (SI-2100)305040002026-06-23
J021305050001Implantmed Plus II (SI-2101)305050002026-06-23
J021305060001Implantmed Plus II (SI-2102)305060002026-06-23
J021305070001Piezomed Module Plus II (SP-210 M)305070002026-06-23
J021122275011EB-75 Endea 16:1122275012018-08-31
J021122279011EB-79 Endea 2:1122279012018-08-31
J021300010031TG-98 L Megagen300010032022-03-30
J021300040031TG-97 L Megagen300040032022-03-30
J021301040001AM-25 A BC Air Motor301040002023-07-11
J021301120001AM-25 BC Air Motor301120002023-07-11
J021302120011WG-57 LT302120012023-07-11
J021302180001WK-66 LT S302180002019-09-10
J021303100021Assistina Twin MB-302303100022022-11-29
J021303980021MB-301 Assistina ONE303980022022-08-24
J021078122001Tip Set: 1E, 2E, 3E, 4E, 5E, 6E078122002023-08-14
J021058492011Scaler Tip 4U058492012023-07-19

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00821925011441DIEGOGyrus ACMI, LLCERL2017-05-11