FDA.report

Zygoma SZ-75

Primary DI
J02130095000
Brand
Zygoma SZ-75
Company
W & H Dentalwerk Bürmoos GmbH
Model
30095000
Device description
Surgical Handpiece for treatment of organic hard tissue
Published
2020-07-30
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

Related Records

Product Codes

CodeName
KMWHandpiece, Rotary Bone Cutting

Product Code Classifications

CodeDeviceSpecialtyClass
KMWHandpiece, Rotary Bone CuttingDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
J02130095000PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental power tool system handpiece, remotely-drivenA hand-held dental device that includes a chuck for attaching a rotary dental endpiece (e.g., drill bits, burs, reamers) intended to be used in dentistry to bore/excavate bones, teeth, and tough tissues. The device does not incorporate a power source (e.g., an AC-powered motor). The rotational power is transferred from the power source to the endpiece via mechanical components (e.g., chains, gears, shafts) incorporated in the handpiece or via an external flexible drive system (e.g., a Bowden cable); the endpiece(s) are not included. This is a reusable device.

Sterilization Methods

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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J021305030141Piezomed Pro Accessory305030142025-09-22
J021305030151Piezomed Pro Accessory305030152025-09-22

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J021101008030S-8 SW & H Dentalwerk Bürmoos GmbHKMW2025-08-26
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04560264557109X-SG93LNAKANISHI INC.KMW2022-02-17
04560264557116X-SG93NAKANISHI INC.KMW2022-02-17
04560264557130X-SG25LNAKANISHI INC.KMW2022-02-17
D762KITBOPR000Implant-OneImplant Logistics, Inc.KMW2021-05-12
D762KITBOPR001Implant-OneImplant Logistics, Inc.KMW2021-05-12
J021304110001S-16 Surgical Handpiece 1:2W & H Dentalwerk Bürmoos GmbHKMW2020-09-15
00845694094290OsteoMedOSTEOMED LLCKMW2020-04-28
00842528123706OsteoMedOSTEOMED LLCKMW2019-11-08
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00842528114551OsteoMedOSTEOMED LLCKMW2018-10-26
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00842528114575OsteoMedOSTEOMED LLCKMW2018-10-26
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