Cleared Traditional

K071965 - I-SURGE

K071965 is an FDA 510(k) clearance for I-SURGE, manufactured by Satelec. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K071965 · Satelec · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
56d
Days
Class 1
Risk

K071965 is an FDA 510(k) clearance for the I-SURGE. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Satelec (Mt. Laurel, US). The FDA issued a Cleared decision on September 10, 2007 after a review of 56 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 Satelec devices

FDA 510(k) Submission Details - K071965

510(k) Number K071965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2007
Decision Date September 10, 2007
Days to Decision 56 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
71d faster than avg
Panel avg: 127d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

EFB Device Classification - Class 1, General Controls

Product Code EFB Handpiece, Air-powered, 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 - EFB Handpiece, Air-powered, Dental

All 90
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K071965.
A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-43
K082716 · A-Dec, Inc. · Jan 2009
A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENT
K082827 · A-Dec, Inc. · Jan 2009
SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS
K073478 · Sybron Dental Specialties, Inc. · Sep 2008
A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TA-98, TA-97, A-DEC/W&H SYNEA HANDPIECE ATTACHMENT
K070663 · A-Dec, Inc. · Jul 2007
LUBRINA, MODEL HIM-1
K070074 · J. Morita USA, Inc. · May 2007
INTERPROXIMAL REDUCTION SYSTEM
K053368 · Dentsply International · Mar 2006