510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Cao Group, Inc.

W Jordan, UT, US

CAO GROUP, INC. appears in FDA device records in W Jordan, UT. FDA records list 33 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
33
PMA records
0
Recall records
1
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Cao Group, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Amd Lasers, LLC510(k), recall

510(k) clearance history

FDA records hold 33 510(k) clearances for Cao Group, Inc. between 2001 and 2026. The busiest year on record is 2006, with 4. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Cao Group, Inc., by decision year
YearClearances
20011
20021
20041
20051
20064
20072
20093
20102
20112
20121
20132
20143
20151
20161
20172
20193
20202
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K254197Picasso Pro Diode Laser (002-00460)GEXSubstantially Equivalent
K201904Monet Curing LaserQNFSubstantially Equivalent
K201475Ultimate Contour, Ultimate Contour MiniPBXSubstantially Equivalent
K181614Sterling Supreme Diode LaserGEXSubstantially Equivalent
K181602Pioneer Elite Diode LaserGEXSubstantially Equivalent
K181601Precise SHP Diode LaserGEXSubstantially Equivalent
K171052Ultimate Contour, Ultimate Contour MiniPBXSubstantially Equivalent
K171986Sterling Supreme Diode LaserGEXSubstantially Equivalent
K160413Sterling 5W Diode LaserGEXSubstantially Equivalent
K150585Ascent 3DEBZSubstantially Equivalent
K142226Pilot Ultra Diode LaserGEXSubstantially Equivalent
K142225Pilot Elite Diode LaserGEXSubstantially Equivalent
K142223Pilot Pro Diode LaserGEXSubstantially Equivalent
K131059PIONEER ELITE DIODE LASERGEXSubstantially Equivalent
K123443PRECISE SHP DIODE LASERGEXSubstantially Equivalent
K113472PRECISE SHP DIODE LASERGEXSubstantially Equivalent
K102359PICASSO/ PICASSO LITE/ PICASSO PERIOGEXSubstantially Equivalent
K103160NUPRO MODEL 13016901LBHSubstantially Equivalent
K100540ASCENT F-COAT MODEL: 006-00097LBHSubstantially Equivalent
K100143PILOT DIODE LASER, MODEL 002-00139GEXSubstantially Equivalent
K092616ASCENT BOND UNIVERSAL ADHESIVE SYSTEM, MODELS 006-00029, 006-00030, 006-00044, 006-00045KLESubstantially Equivalent
K091300ASCENT PORCELAIN PRIMER, MODEL 006-00078, 00600079KLESubstantially Equivalent
K083142PICASSO LASER SYSTEMGEXSubstantially Equivalent
K070070ASCENT DENTAL CLEANSERLBHSubstantially Equivalent
K070413ASCENT UNIVERSAL ADHESIVE, MODEL 006-00028KLESubstantially Equivalent
K062619DENLASER 800 PLUSGEXSubstantially Equivalent
K062886ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019EBCSubstantially Equivalent
K061366DENLASER 800 PLUSGEXSubstantially Equivalent
K061341PALMLIGHT 10, MODEL 001-00030EBZSubstantially Equivalent
K053089ASCENT PIT & FISSURE SEALANTEBCSubstantially Equivalent
K041392SONX 35 ULTRASONIC BLEACHING SYSTEM; SONIWHITE ULTRA SONIC, MODEL QUICK WHITE USEEGSubstantially Equivalent
K020057PALMLIGHTEBZSubstantially Equivalent
K003541DENLASER, MODEL 800GEXSubstantially Equivalent

Registered establishments

FDA registered establishments for Cao Group, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
17250063003258642CAO GROUP, INC.4628 WEST SKYHAWK DRIVE, W Jordan, UT 84084 US2026and 7 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2349-2010Picasso/Picasso Lite lasers Intended use: Dentistry.Product is noncompliant with the Federal laser product performance standard in certain requirements. The ON/OFF key on some of the Picasso/Picasso Lite lasers could be removed with force while the key was in the ON position.Terminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain