FDA 510(k) Premarket Notification K040153: I-TEC PORTABLE DENTAL OPERATORY

Submission Details & Decision

Normalized public record details for 510(k) notification K040153.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K040153

Applicant / Sponsor

Indigenous Peoples Technology and Education Center

Device Name

I-TEC PORTABLE DENTAL OPERATORY

Product Code

EBW

Decision Date

2004-05-21

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Dental (DE)

Clearance Type

Traditional

Third Party Flag

Date Received

2004-01-23

Related Establishments / Registrations

BRASSELER U.S.A. DENTAL, LLC Registration: 1032227 View Registration
TOYO MEDICAL CO. Registration: 1054713 View Registration
NORDENT MFG., INC. Registration: 1419489 View Registration
NSK AMERICA CORP. Registration: 1422375 View Registration
Kerr Corporation Registration: 2024312 View Registration
TULSA DENTAL PRODUCTS LLC Registration: 2320721 View Registration
DENTALEZ, INC., STARDENTAL DIVISION Registration: 2520265 View Registration
Bien-Air Dental SA Registration: 3003268570 View Registration
OLSEN INDUSTRIA E COMERCIO S/A Registration: 3003548115 View Registration
KAVO DENTAL GMBH Registration: 3003637274 View Registration
VECTOR RESEARCH & DEVELOPMENT Registration: 3003934980 View Registration
CODENT TECHNICAL INDUSTRY CO.,LTD. Registration: 3004082152 View Registration
DENTSPLY SIRONA INC Registration: 3004884150 View Registration
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD Registration: 3005581016 View Registration
GoldenDent Registration: 3005972890 View Registration
NOBEL BIOCARE DISTRIBUTION CENTER BV Registration: 3006540014 View Registration
CEFLA S.C. Registration: 3006610845 View Registration
Handpiece Headquarters Registration: 3007007357 View Registration
DIO Corporation Registration: 3007126709 View Registration
W&H IMPEX INC. Registration: 3007279848 View Registration
MICRO-NX CO., LTD. Registration: 3007345485 View Registration
ADIN DENTAL IMPLANT SYSTEMS LTD. Registration: 3007518363 View Registration
SAESHIN PRECISION CO., LTD. Registration: 3007958831 View Registration
PALTOP ADVANCED DENTAL SOLUTIONS LTD Registration: 3009161350 View Registration
SYCOTEC GMBH & CO KG Registration: 3009302876 View Registration
Foshan CICADA Dental Instrument Co., Ltd. Registration: 3009768364 View Registration
Millstone Medical Outsourcing LLC Registration: 3010097171 View Registration
Synergy Health Marseille SAS Registration: 3010162973 View Registration
HIOSSEN INC. Registration: 3010185635 View Registration
Arthrex, Inc. Registration: 3010331645 View Registration
TRIBE MEDICAL GROUP Registration: 3010400367 View Registration
SAEYANG CO., LTD. Registration: 3010551934 View Registration
W&H DENTALWERK BUERMOOS GMBH - SITE 2 Registration: 3011300255 View Registration
PRISMATIK DENTALCRAFT, INC. Registration: 3011649314 View Registration
DENTSPLY IH BV Registration: 3011824442 View Registration
Kerr Corporation Registration: 3012477813 View Registration
Bien-Air Portugal Unipessoal LDA Registration: 3013576763 View Registration
TRANSMEDIC HEALTHCARE SDN BHD Registration: 3013767421 View Registration
Arthrex Singapore Pte Ltd. Registration: 3014004349 View Registration
JMU DENTAL, INC Registration: 3014683120 View Registration
FOSHAN COXO MEDICAL INSTRUMENT CO., LTD. Registration: 3014953747 View Registration
Arthrex Manufacturing Inc. Registration: 3015231789 View Registration
Ormco Corporation Registration: 3015272949 View Registration
A-dec, Inc. Registration: 3015729 View Registration
VIETMEDICAL DISTRIBUTION JOINT STOCK COMPANY Registration: 3016727307 View Registration
DENTIUM CO.,LTD(ICT BRANCH) Registration: 3017403245 View Registration
ASEPTICO, INC. Registration: 3017604 View Registration
Arthrex Australia Pty Ltd. Registration: 3019269298 View Registration
Arthrex Colombia SAS Registration: 3021226419 View Registration
BIOCELLS DISCOVERIES INTERNACIONAL (BIOCELLS) Registration: 3021336182 View Registration
SANKO ELECTRONICS CORPORATION Registration: 3025599428 View Registration
FORCE ENGINEERING CO.LTD Registration: 3025764223 View Registration
Arthrex Chile SPA Registration: 3027339877 View Registration
DCI International, LLC Registration: 3029780 View Registration
TANI ELECTRONICS CORPORATION Registration: 3030091468 View Registration
ONVET MEDICAL CANADA INC Registration: 3030126955 View Registration
Arthrex Logistic Center Canada Registration: 3030926959 View Registration
DENTIUM CO.,LTD(ICT BRANCH) Registration: 3031093388 View Registration
GUANGXI EHALL MEDICAL TECHNOLOGY CO.,LTD Registration: 3036269993 View Registration
OKETZ LOGISTICS LLC Registration: 3038718579 View Registration
KAVO DENTAL GMBH Registration: 8010493 View Registration
ANTHOGYR Registration: 8020776 View Registration
SATELEC-ACTEON GROUP Registration: 8044015 View Registration
NAKANISHI INC. Registration: 9611253 View Registration
BIEN-AIR DENTAL SA Registration: 9614446 View Registration
SIRONA DENTAL SYSTEMS GMBH Registration: 9614977 View Registration
W&H DENTALWERK BUERMOOS GMBH Registration: 9681479 View Registration
Sirona Dental Systems GmbH Registration: 9681851 View Registration
BONART CO. LTD. Registration: 9710363 View Registration

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