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510(k) K122725

Device
TANDA PEARL, ULTRAWYTE, PEARL
Applicant
SYNERON BEAUTY
510(k) number
K122725
Product code
EEG  
Decision
Substantially Equivalent (SESE)
Decision date
2012-11-27
Date received
2012-09-05
Regulation
872.6475
Classification name
Heat Source For Bleaching Teeth
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JANICE M HOGAN
Address
1835 Market St., 29th Floor Philedelphia PA US 19103 19103

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EEG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K110888ABSOLUTE WHITE LIGHTDr. Fresh, Inc.2012-01-12
K063704BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101Beks Incorporated2007-02-20
K052040QUICKSMILECosmetic Dental Materials, Inc.2005-10-18
K041392SONX 35 ULTRASONIC BLEACHING SYSTEM; SONIWHITE ULTRA SONIC, MODEL QUICK WHITE USCAO Group, Inc.2004-11-08
K042153SOUTH BEACH SMILE LIGHT WHITENING SYSTEMDentovations, Inc.2004-11-08
K895174UNION BROACH BLEACHING LIGHTUnion Broach, Div. Moyco Industries, Inc.1990-04-13
K884937BEEHIVE-64 OR BEEHIVE-32, DIGITAL EEG RECORDINGGrass-Telefactor Product Group1989-04-14
K862385SCHEIN BLEACHING UNITHenry Schein, Inc.1986-10-30
K854692MONARCH II BLEACHING INSTRUMENTAlmore Intl., Inc.1986-05-12
K832179HOT PROBE MODEL 6001Analytic Technology1983-10-04
K790378REYNOLDS BLEACHING PROCESSReynolds Laboratories1979-04-10

Legacy Summary#

summary

FDA Review#

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