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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 128d · 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 64
Devices cleared under the same product code (EGS) and FDA review panel - the closest regulatory comparables to K060377.
MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH
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EXCEL CONTRA ANGLE HANDPIECE
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ANTHOGYR CONTRA ANGLES AND HANDPIECES
K060317 · Est. Anthogyr · Apr 2006
E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101
K051077 · Aseptico, Inc. · May 2005
AX'S ENDO 04, 06, 08, 2.5, 40 , MODELS 50100206, 50100217, 50100218, 50100230, 50100232
K042171 · Micro-Mega Societe Anonyme · Nov 2004
B&R DEVICE
K032925 · Ronvig A/S · Dec 2003
K060377 · DR DISPOSABLE PROPHY ANGLE MODEL H310
Download PDF FDA Summary Dental Resources