Cleared Traditional

K060377 - DR DISPOSABLE PROPHY ANGLE MODEL H310

K060377 is an FDA 510(k) clearance for DR DISPOSABLE PROPHY ANGLE MODEL H310, manufactured by Dental Resources. The device is a Class 1 Dental device with product code EGS cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K060377 · Dental Resources · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
71d
Days
Class 1
Risk

K060377 is an FDA 510(k) clearance for the DR DISPOSABLE PROPHY ANGLE MODEL H310. Classified as Handpiece, Contra- And Right-angle Attachment, Dental (product code EGS), Class I - General Controls.

Submitted by Dental Resources (Maple Lake, US). The FDA issued a Cleared decision on April 26, 2006 after a review of 71 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 Dental Resources devices

FDA 510(k) Submission Details - K060377

510(k) Number K060377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2006
Decision Date April 26, 2006
Days to Decision 71 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 127d · This submission: 71d
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 37
Devices cleared under the same product code (EGS) and FDA review panel - the closest regulatory comparables to K060377.
TORQTECH
K103697 · J. Morita USA, Inc. · Jan 2012
MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECE
K111532 · Anthogyr Sas · Oct 2011
STRONG DENTAL HANDPIECES
K100192 · Saeshin Precision Co., Ltd. · Feb 2010
E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101
K051077 · Aseptico, Inc. · May 2005
AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88 8:1 REDUCTION CONTRANGLE: AHP-88MP 8:1 REDUCTION CONTRANGLE - PUSH BUTTON
K020137 · Aseptico, Inc. · Mar 2002
SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES, S-9, S-10, S-11
K011061 · W&H Dentalwerk Buermoos GmbH · Jun 2001