Cleared Traditional

MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH

K092053 · Handpiece Headquarters · Dental
Aug 2009
Decision
44d
Days
Class 1
Risk

About This 510(k) Submission

K092053 is an FDA 510(k) clearance for the MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH, a Handpiece, Contra- And Right-angle Attachment, Dental (Class I — General Controls, product code EGS), submitted by Handpiece Headquarters (Placentia, US). The FDA issued a Cleared decision on August 20, 2009, 44 days after receiving the submission on July 7, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K092053 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 2009
Decision Date August 20, 2009
Days to Decision 44 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EGS — Handpiece, Contra- And Right-angle Attachment, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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