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FDA 510(k)

I-TEC PORTABLE DENTAL OPERATORY

K-Number: K040153 · 2004-05-21

ApplicantIndigenous Peoples Technology and Education Center
Decision Date2004-05-21
Product CodeEBW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

I-TEC PORTABLE DENTAL OPERATORY is the device name listed in this FDA 510(k) record. The listed applicant is Indigenous Peoples Technology and Education Center. It received FDA 510(k) clearance on 2004-05-21 under 510(k) number K040153. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I-TEC PORTABLE DENTAL OPERATORY?

I-TEC PORTABLE DENTAL OPERATORY is a medical device that received FDA 510(k) clearance on 2004-05-21. The listed applicant is Indigenous Peoples Technology and Education Center. The 510(k) number is K040153.

When did I-TEC PORTABLE DENTAL OPERATORY receive FDA 510(k) clearance?

I-TEC PORTABLE DENTAL OPERATORY received FDA 510(k) clearance on 2004-05-21, under 510(k) number K040153.

Who is the listed applicant for I-TEC PORTABLE DENTAL OPERATORY?

The FDA 510(k) record lists Indigenous Peoples Technology and Education Center as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I-TEC PORTABLE DENTAL OPERATORY?

The FDA product code for I-TEC PORTABLE DENTAL OPERATORY is EBW.

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Related Devices (Code: EBW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251407Motor Handpiece and Control Unit (SDI10)Saeshin Precision Co., Ltd.K251701Star E900 Electric SystemDentalez, Inc., Stardental DivisionK251811Motor and Apex Module (MaAM)Dentsply Sirona, Inc.K231562ELEC ENGINE (Model: ISE-170L)Micro-Nx Co., Ltd.K242646Dental Implant UnitGuilin Aesthedent Medical Instruments Co., Ltd.K233288NLZ Built-In Motor SystemNakanishi, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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