Cleared Traditional

K092053 - MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH

K092053 is an FDA 510(k) clearance for MAXIMA-M STRAIGHT ATTACHMENT, manufactured by Handpiece Headquarters. The device is a Class 1 Dental device with product code EGS cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K092053 · Handpiece Headquarters · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
44d
Days
Class 1
Risk

K092053 is an FDA 510(k) clearance for the MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH. Classified as Handpiece, Contra- And Right-angle Attachment, Dental (product code EGS), Class I - General Controls.

Submitted by Handpiece Headquarters (Placentia, US). The FDA issued a Cleared decision on August 20, 2009 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Handpiece Headquarters devices

FDA 510(k) Submission Details - K092053

510(k) Number K092053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 128d · This submission: 44d
Pathway characteristics
Predicate-based equivalence.

EGS Device Classification - Class 1, General Controls

Product Code EGS Handpiece, Contra- And Right-angle Attachment, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EGS Handpiece, Contra- And Right-angle Attachment, Dental

All 52
Devices cleared under the same product code (EGS) and FDA review panel - the closest regulatory comparables to K092053.
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K060317 · Est. Anthogyr · Apr 2006
DR DISPOSABLE PROPHY ANGLE MODEL H310
K060377 · Dental Resources · Apr 2006