Home GUDID J021101008010 S-8 R
Primary DI J021101008010
Brand S-8 R
Company W & H Dentalwerk Bürmoos GmbH
Model 10100801
Device description Micro-Saw Handpiece reziprocal
Published 2025-08-26
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 Product Codes# Code, Name table Code Name KMW Handpiece, Rotary Bone Cutting
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KMW Handpiece, Rotary Bone Cutting Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status J021101008010 Direct Marking HIBCC 0 J021101008011 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Dental surgical power tool motorized handpiece/set, electric An electrically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade] for drilling, cutting, polishing, and/or inserting procedures involving bones and tough tissues during a dental surgical procedure. It includes an electric motor and the appropriate attachments (e.g., angle adaptor, torque multiplier) at its distal end for connection of the endpieces and may include a rechargeable battery or a control unit; the endpieces are not included. This is a reusable device.
Sterilization Methods# Method table 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 Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00810126043153 SM7 US ( Complete Set ) HIOSSEN, INC. KMW 2026-01-09 00810126043160 S200EML (Contra) Dental Surgery Hand Piece HIOSSEN, INC. KMW 2026-01-09 04589551388813 SG20M NAKANISHI INC. KMW 2025-08-28 04589551388820 X-SG20ML NAKANISHI INC. KMW 2025-08-28 04560264576940 SG20M NAKANISHI INC. KMW 2025-08-28 04560264576957 X-SG20ML NAKANISHI INC. KMW 2025-08-28 J021101008011 S-8 R W & H Dentalwerk Bürmoos GmbH KMW 2025-08-26 J021101008021 S-8 O W & H Dentalwerk Bürmoos GmbH KMW 2025-08-26 J021101008031 S-8 S W & H Dentalwerk Bürmoos GmbH KMW 2025-08-26 J021101008020 S-8 O W & H Dentalwerk Bürmoos GmbH KMW 2025-08-26 J021101008030 S-8 S W & H Dentalwerk Bürmoos GmbH KMW 2025-08-26 06974267891104 COXO Foshan COXO Medical Instrument Co.,Ltd. KMW 2024-07-04 06974267891067 COXO Foshan COXO Medical Instrument Co.,Ltd. KMW 2024-03-30 J021300320021 WS-75 LG surgical handpiece, 20:1, MIS W & H Dentalwerk Bürmoos GmbH KMW 2023-07-11 J021300320020 WS-75 LG surgical handpiece, 20:1, MIS W & H Dentalwerk Bürmoos GmbH KMW 2023-07-11 04589551382446 X-SG93L NAKANISHI INC. KMW 2022-02-17 04589551382453 X-SG93 NAKANISHI INC. KMW 2022-02-17 04589551382460 X-SG25L NAKANISHI INC. KMW 2022-02-17 04560264557109 X-SG93L NAKANISHI INC. KMW 2022-02-17 04560264557116 X-SG93 NAKANISHI INC. KMW 2022-02-17 04560264557130 X-SG25L NAKANISHI INC. KMW 2022-02-17 D762KITBOPR000 Implant-One Implant Logistics, Inc. KMW 2021-05-12 D762KITBOPR001 Implant-One Implant Logistics, Inc. KMW 2021-05-12 00840117305151 Plastic Overbed Table, H Base, Silver Vein, Grey Dynarex Corporation KMW 2021-04-22 00840117305168 Plastic Overbed Table, H Base, Silver Vein, Cherry Dynarex Corporation KMW 2021-04-22 00840117305182 Plastic Overbed Table, H Base, Silver Vein, Mahogany Dynarex Corporation KMW 2021-04-22 00814913029603 SM3 HIOSSEN, INC. KMW 2021-01-20 J021304110001 S-16 Surgical Handpiece 1:2 W & H Dentalwerk Bürmoos GmbH KMW 2020-09-15 J02130095000 Zygoma SZ-75 W & H Dentalwerk Bürmoos GmbH KMW 2020-07-30 00845694094290 OsteoMed OSTEOMED LLC KMW 2020-04-28