Product Code: EFB


Products Classified as EFB

1148Handpiece, Air-powered, DentalDental Handpiece And Accessories.

Total Product Life Cycle (TPLC) Devices

1148Handpiece, Air-powered, DentalDental Handpiece And Accessories.

FDA Consensus Standards

Handpiece, Air-Powered, Dental [32309]21 CFR §872.4200 🔎
Handpiece, Air-Powered, Dental [37950]21 CFR §872.4200 🔎
Handpiece, Air-Powered, Dental [34709]21 CFR §872.4200 🔎
Handpiece, Air-Powered, Dental [32013]21 CFR §872.4200 🔎
Handpiece, Air-Powered, Dental [31729]21 CFR §872.4200 🔎
Handpiece, Air-Powered, Dental [31450]21 CFR §872.4200 🔎
Handpiece, Air-Powered, Dental [34868]21 CFR §872.4200 🔎

Pre-market Notifications for EFB

K221814OK HandpieceJaintek Co.,Ltd
K221548Dental Air Polishing HandpieceGuilin Woodpecker Medical Instrument Co., Ltd.
K212910Dental High-speed Turbine Handpiece, Dental Low-speed Turbine HandpieceShenzhen Carejoy Technology Co., Ltd.
K203791Stainless TurbineNAKANISHI INC.
K202786Dental Low-speed Handpieces And AccessoriesMicroP Technology (Taiwan), Inc.
K192409Midwest Rhino XE And Air Motor MDentsply Sirona
K192412SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed HandpieceDentalEZ, Inc.
K190508EVO 450 Series High Speed HandpiecesTTBIO CORP.
K190509Lubrina 2J. Mortia USA, Inc.
K181900Dental High Speed Handpiece, Dental Low Speed HandpieceFoshan CICADA Dental Instrument Co., Ltd.
K181691High-speed Air Turbine Handpiece / Low-speed Air Turbine HandpieceFoshan Wenjian Medical Instrument Co., Ltd.
K181110PROPHYflex 4Kaltenbach & Voigt GmbH
K173943Dental High-speed Handpiece And AccessoriesMicroP Technology (Taiwan), Inc.
K173465Concentrix MX-AC High-Speed HandpieceDentalEZ, Inc.
K172543High-speed Turbine Handpieces For Single UseBeijing Dongbo Dental Handpiece Co., Ltd.

Global Unique Device Identification Database

00304040099520Handpiece, air-powered, dental
00304040064382Handpiece, air-powered, dental
00304040064375Handpiece, air-powered, dental
10304040063542Handpiece, air-powered, dental
10304040063528Handpiece, air-powered, dental
00304040062098Handpiece, air-powered, dental
00304040062081Handpiece, air-powered, dental
00304040062074Handpiece, air-powered, dental
00304040062067Handpiece, air-powered, dental
00304040062029Handpiece, air-powered, dental
00304040062012Handpiece, air-powered, dental
00304040062005Handpiece, air-powered, dental
00304040061992Handpiece, air-powered, dental
00615375005118HANDPIECE, AIR-POWERED, DENTAL
00615375005095HANDPIECE, AIR-POWERED, DENTAL

Maude Adverse Events

NSKHANDPIECE, AIR-POWERED, DENTALNAKANISHI INC.2020-03-23
MIDWEST STYLUS LITE 360SSIRONA DENTAL SYSTEMS GMBH2020-03-06
NSKHANDPIECE, AIR-POWERED, DENTALNAKANISHI INC.2020-02-11
HANDPIECE, AIR POWERED DENTALKAVO DENTAL GMBH / KALTENBACH AND VOIGT GMBH2020-02-03
MIDWEST PHOENIX PRO - ATC BACKENDSIRONA DENTAL SYSTEMS GMBH2020-02-01
MIDWEST STYLUS PLUS SPKSIRONA DENTAL SYSTEMS GMBH2020-02-01
MIDWEST E PLUS 1:5 HIGH SPEED CONTRA ANGLE ATTACHMENTSIRONA DENTAL SYSTEMS GMBH2020-02-01
MIDWEST STYLUS MINI 540SSIRONA DENTAL SYSTEMS GMBH2020-02-01
MIDWEST STYLUS PLUS SPKSIRONA DENTAL SYSTEMS GMBH2020-02-01
MIDWEST STYLUS ATC HANDPIECESIRONA DENTAL SYSTEMS GMBH2020-02-01
MIDWEST E PLUS 1:1 STRAIGHT ATTACHMENTSIRONA DENTAL SYSTEMS GMBH2020-02-01
MIDWEST STYLUS ATC MINI HANDPIECESIRONA DENTAL SYSTEMS GMBH2020-02-01
MIDWEST STYLUS MINI 541SSIRONA DENTAL SYSTEMS GMBH2020-02-01
MIDWEST E PRO 1:5SIRONA DENTAL SYSTEMS GMBH2020-02-01
MIDWEST STYLUS PLUS SPMSIRONA DENTAL SYSTEMS GMBH2020-02-01
MIDWEST PHOENIXSIRONA DENTAL SYSTEMS GMBH2020-02-01
LUX M05LKAVO DENTAL / KALTENBACH & VOIGT2020-01-30
MIDWEST TRADITION HANDPIECESIRONA DENTAL SYSTEMS GMBH2020-01-28
MIDWEST TRADITION HANDPIECESIRONA DENTAL SYSTEMS GMBH2020-01-28
MIDWEST TRADITION HANDPIECESIRONA DENTAL SYSTEMS GMBH2020-01-28
MIDWEST E PLUS 1:5SIRONA DENTAL SYSTEMS GMBH2020-01-28
MIDWEST TRADITION HANDPIECESIRONA DENTAL SYSTEMS GMBH2020-01-28
MIDWEST TRADITIONSIRONA DENTAL SYSTEMS GMBH2020-01-28
MIDWEST STYLUS HANDPIECESIRONA DENTAL SYSTEMS GMBH2020-01-28
MIDWEST TRADITION HANDPIECESIRONA DENTAL SYSTEMS GMBH2020-01-28
MIDWEST STYLUS ATC HANDPIECESIRONA DENTAL SYSTEMS GMBH2020-01-28
MIDWEST E PRO 1:5SIRONA DENTAL SYSTEMS GMBH2020-01-28
MIDWEST TRADITION PRO HANDPIECESIRONA DENTAL SYSTEMS GMBH2020-01-28
MIDWEST TRADITION HANDPIECESIRONA DENTAL SYSTEMS GMBH2020-01-28
MIDWEST TRADITION HANDPIECESIRONA DENTAL SYSTEMS GMBH2020-01-28
MIDWEST STYLUS HANDPIECESIRONA DENTAL SYSTEMS GMBH2020-01-28
MIDWEST E MINI 1:5SIRONA DENTAL SYSTEMS GMBH2020-01-28
MIDWEST TRADITION HANDPIECESIRONA DENTAL SYSTEMS GMBH2020-01-28
MIDWEST STYLUS HANDPIECESIRONA DENTAL SYSTEMS GMBH2020-01-28
MIDWEST PHOENIX PROSIRONA DENTAL SYSTEMS GMBH2020-01-28
MIDWEST TRADITION HANDPIECESIRONA DENTAL SYSTEMS GMBH2020-01-28
MIDWEST TRADITION HANDPIECESIRONA DENTAL SYSTEMS GMBH2020-01-28
MIDWEST TRADITIONSIRONA DENTAL SYSTEMS GMBH2020-01-28
ATR TECNIKA DIGITAL TORQUE CONTROL MOTORTULSA DENTAL PRODUCTS LLC2019-12-31
SMARTTORQUE S609 CKAVO DENTAL GMBH2019-12-20
MIDWEST TRADITION NON FIBER OPTICSIRONA DENTAL SYSTEMS GMBH2019-10-31
MIDWEST TRADITION LEVER CHUCK - FIXED BACKENDSIRONA DENTAL SYSTEMS GMBH2019-10-31
MIDWEST TRADITION L NON FIBER OPTICSIRONA DENTAL SYSTEMS GMBH2019-10-31
MIDWEST TRADITION PLUS FIXED BACK ENDSIRONA DENTAL SYSTEMS GMBH2019-10-31
MIDWEST TRADITION PLUS COUPLER BACK END WITH FIBER OPTICSIRONA DENTAL SYSTEMS GMBH2019-10-31
MIDWEST E PLUS 1:5SIRONA DENTAL SYSTEMS GMBH2019-10-31
MIDWEST PHOENIX PRO - ATC BACKENDSIRONA DENTAL SYSTEMS GMBH2019-10-31
MIDWEST STYLUS ATC HANDPIECE - ATC 890SIRONA DENTAL SYSTEMS GMBH2019-10-31
MIDWEST TRADITION PLUS HANDPIECESIRONA DENTAL SYSTEMS GMBH2019-10-31
MIDWEST STYLUS LITE 361SSIRONA DENTAL SYSTEMS GMBH2019-10-31

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