FDA.reportPublic FDA data

Screw Holder for WS-90

Primary DI
J021069909001
Brand
Screw Holder for WS-90
Company
W & H Dentalwerk Bürmoos GmbH
Model
06990900
Device description
Accessory for WS-90
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KMWHandpiece, Rotary Bone Cutting

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMWHandpiece, Rotary Bone CuttingDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J021069909001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
300238441
Device count
1
DM exempt
true
Serial number
true

Other Devices From This Company#

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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
00810126043153SM7 US ( Complete Set )HIOSSEN, INC.KMW2026-01-09
00810126043160S200EML (Contra) Dental Surgery Hand PieceHIOSSEN, INC.KMW2026-01-09
04589551388813SG20MNAKANISHI INC.KMW2025-08-28
04589551388820X-SG20MLNAKANISHI INC.KMW2025-08-28
04560264576940SG20MNAKANISHI INC.KMW2025-08-28
04560264576957X-SG20MLNAKANISHI INC.KMW2025-08-28
J021101008011S-8 RW & H Dentalwerk Bürmoos GmbHKMW2025-08-26
J021101008021S-8 OW & H Dentalwerk Bürmoos GmbHKMW2025-08-26
J021101008031S-8 SW & H Dentalwerk Bürmoos GmbHKMW2025-08-26
J021101008010S-8 RW & H Dentalwerk Bürmoos GmbHKMW2025-08-26
J021101008020S-8 OW & H Dentalwerk Bürmoos GmbHKMW2025-08-26
J021101008030S-8 SW & H Dentalwerk Bürmoos GmbHKMW2025-08-26
06974267891104COXOFoshan COXO Medical Instrument Co.,Ltd.KMW2024-07-04
06974267891067COXOFoshan COXO Medical Instrument Co.,Ltd.KMW2024-03-30
J021300320021WS-75 LG surgical handpiece, 20:1, MISW & H Dentalwerk Bürmoos GmbHKMW2023-07-11
J021300320020WS-75 LG surgical handpiece, 20:1, MISW & H Dentalwerk Bürmoos GmbHKMW2023-07-11
04589551382446X-SG93LNAKANISHI INC.KMW2022-02-17
04589551382453X-SG93NAKANISHI INC.KMW2022-02-17
04589551382460X-SG25LNAKANISHI INC.KMW2022-02-17
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
00840117305151Plastic Overbed Table, H Base, Silver Vein, GreyDynarex CorporationKMW2021-04-22
00840117305168Plastic Overbed Table, H Base, Silver Vein, CherryDynarex CorporationKMW2021-04-22
00840117305182Plastic Overbed Table, H Base, Silver Vein, Mahogany Dynarex CorporationKMW2021-04-22
00814913029603SM3HIOSSEN, INC.KMW2021-01-20
J021304110001S-16 Surgical Handpiece 1:2W & H Dentalwerk Bürmoos GmbHKMW2020-09-15
J02130095000Zygoma SZ-75W & H Dentalwerk Bürmoos GmbHKMW2020-07-30