Cleared Traditional

K000049 - SUNI MAX

K000049 is an FDA 510(k) clearance for SUNI MAX, manufactured by Satelec. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K000049 · Satelec · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
88d
Days
Class 1
Risk

K000049 is an FDA 510(k) clearance for the SUNI MAX. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Satelec (Wellesley, US). The FDA issued a Cleared decision on April 4, 2000 after a review of 88 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 - K000049

510(k) Number K000049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2000
Decision Date April 04, 2000
Days to Decision 88 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
39d faster than avg
Panel avg: 127d · This submission: 88d
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 K000049.
TULSA CONTRA ANGLES
K012720 · Dentsply Intl. · Nov 2001
W & H ASSISTINA
K010127 · A-Dec, Inc. · Oct 2001
RAPIDD HIGHSPEED DENTAL HANDPIECE
K003518 · Dentsply Intl. · Jan 2001
SYNEA - LS LOW-SPEED HANDPIECE
K993526 · A-Dec, Inc. · Jan 2000
LC COMPOSITE
K991492 · Harry J. Bosworth Co. · Dec 1999
ENDO-EZE MOTOR AND HANDPIECE
K992380 · Ultradent Products, Inc. · Oct 1999