Maxima XTEND Handpiece Maintenance System

Q: What is the product code of K143183?

The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.

FDA 510(k) K143183 · Handpiece Headquarters

Substantially Equivalent

510(k) numberK143183

Submission

Device name: Maxima XTEND Handpiece Maintenance System
Applicant: Handpiece Headquarters
Placentia, CA, US
Received: November 5, 2014
Decision date: February 17, 2015
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: EFB – Handpiece, Air-Powered, Dental
Device class: Class I (low risk)
Regulation: 21 CFR 872.4200
Specialty: Dental

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More from Ttbio Corp.

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K141125	U-Type Contra Angle, U-Type Sectional Contra AngleEGS · Traditional	10/23/2014SE
K100389	HHC Push-Button Replacement Turbine for Midwest Tradition Handpiece Model MW Turbine…EFB · Traditional	08/12/2010SE
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Questions and answers

When was Maxima XTEND Handpiece Maintenance System cleared by the FDA?

Maxima XTEND Handpiece Maintenance System (K143183) received a 510(k) decision of Substantially Equivalent on February 17, 2015, 104 days after the submission was received.

What is the product code of K143183?

The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.