FDA.reportPublic FDA data

Piezomed Pro M-PH350

Primary DI
J021305010001
Brand
Piezomed Pro M-PH350
Company
W & H Dentalwerk Bürmoos GmbH
Model
30501000
Device description
Piezomed Pro Handpiece
Published
2025-07-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
J021305010000Direct MarkingHIBCC0
J021305010001PrimaryHIBCC0

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
300238441
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
J021058494011Scaler Tip 1R058494012023-07-19
J021063680001Scaler Tip 2E063680002023-07-19
J021063684001Scaler Tip 2R063684002023-07-19
J021063685001Scaler Tip 3Rm063685002023-07-19
J021063686001Scaler Tip 3Rd063686002023-07-19
J021078123001Scaler Tip 4E078123002023-07-19
J021078124001Scaler Tip 5E078124002023-07-19
J021079656001Scaler Tip 5P079656002023-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327652703N/ASTRYKER CORPORATIONDZI2026-04-15
07613327652697N/ASTRYKER CORPORATIONDZI2026-04-13
07613327652710PROstepSTRYKER CORPORATIONDZI2026-04-13
07613327652727N/ASTRYKER CORPORATIONDZI2026-04-13
07613327652734N/ASTRYKER CORPORATIONDZI2026-04-13
07613327654127TPXSTRYKER CORPORATIONDZI2026-04-13
07613327652741N/ASTRYKER CORPORATIONHWE2026-03-25
07613327652741N/ASTRYKER CORPORATIONDZI2026-03-25
07613327652758N/ASTRYKER CORPORATIONHWE2026-03-25
07613327652758N/ASTRYKER CORPORATIONDZI2026-03-25
07613327652789N/ASTRYKER CORPORATIONHWE2026-03-25
07640187462302Power Tool TL Attachment 2.5mmBonebridge AGHWE2025-10-17
07613327649161T2, PANGEAStryker GmbHHWE2025-09-25
07630055508096PM2-Nose MIS D150Bien-Air Surgery SAERL2025-03-21
07630055512604PM2-Nose MIS P160Bien-Air Surgery SAERL2025-03-21
07630055508072PM2-S MISBien-Air Surgery SAERL2025-03-21
07630055508065PM2-A MISBien-Air Surgery SAERL2025-03-20
07613327566000T2 ALPHAStryker GmbHHWE2024-03-01
07613327566055T2 ALPHAStryker GmbHHWE2024-03-01
07613327566079T2 ALPHAStryker GmbHHWE2024-03-01
07630055506375HS-Handpiece,straight,70mm,80kBien-Air Surgery SAERL2023-02-22
07630055506382HS-Handpiece,angled,70mm,80kBien-Air Surgery SAERL2023-02-22
07630055506399HS-Handpiece,angled,70mm,80kBien-Air Surgery SAERL2023-02-22
07630055506405HS-Handpiece,angled,95mm,80kBien-Air Surgery SAERL2023-02-22
07630055506412HS-Handpiece, angled,125mm,80kBien-Air Surgery SAERL2023-02-22
07630055506429HS-Handpiece,angled,150mm,80kBien-Air Surgery SAERL2023-02-22
07630055506467Micro Ear Drill, 12kBien-Air Surgery SAERL2023-02-22
07630055507815High-Speed Micro-Motor without cableBien-Air Surgery SAERL2023-02-22
07630055507822Cable for HS-Micro-Motor,smallBien-Air Surgery SAERL2023-02-22
07630055507839High-Speed Micro-Motor without cableBien-Air Surgery SAERL2023-02-22