Cleared Traditional

K122725 - TANDA PEARL, ULTRAWYTE, PEARL

K122725 is an FDA 510(k) clearance for TANDA PEARL, manufactured by Syneron Beauty. The device is a Class 1 Dental device with product code EEG cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K122725 · Syneron Beauty · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2012
Decision
83d
Days
Class 1
Risk

K122725 is an FDA 510(k) clearance for the TANDA PEARL, ULTRAWYTE, PEARL. Classified as Heat Source For Bleaching Teeth (product code EEG), Class I - General Controls.

Submitted by Syneron Beauty (Philedelphia, US). The FDA issued a Cleared decision on November 27, 2012 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6475 - 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 - K122725

510(k) Number K122725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2012
Decision Date November 27, 2012
Days to Decision 83 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
45d faster than avg
Panel avg: 128d · This submission: 83d
Pathway characteristics
Predicate-based equivalence.

EEG Device Classification - Class 1, General Controls

Product Code EEG Heat Source For Bleaching Teeth
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6475
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 - EEG Heat Source For Bleaching Teeth

Devices cleared under the same product code (EEG) and FDA review panel - the closest regulatory comparables to K122725.
ABSOLUTE WHITE LIGHT
K110888 · Dr. Fresh, Inc. · Jan 2012
BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101
K063704 · Beks Incorporated · Feb 2007
QUICKSMILE
K052040 · Cosmetic Dental Materials, Inc. · Oct 2005
SONX 35 ULTRASONIC BLEACHING SYSTEM
K041392 · CAO Group, Inc. · Nov 2004
SOUTH BEACH SMILE LIGHT WHITENING SYSTEM
K042153 · Dentovations, Inc. · Nov 2004
MONARCH II BLEACHING INSTRUMENT
K854692 · Almore Intl., Inc. · May 1986