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Data / Medical devices / United States / Cao Group, Inc.

Cao Group, Inc.: FDA-registered device maker in W Jordan, UT, United States, 18 510(k) clearances

Cao Group, Inc. is registered with the FDA (registration 1725006) in W Jordan, UT, United States. It lists 17 device types. The FDA files 18 510(k) clearances under its listings, the newest dated March 11, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
1725006
FEI number
3003258642
Address
4628 West Skyhawk Drive, W Jordan, UT, United States, 84084
Owner or operator
CAO Group, Inc. (9043755)
Roles
Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
First device listed
June 29, 2005
Registered through
2026
Brand names listed
ASCENT OLX, ASCENT PX, Acuity Direct X-Ray Photon Detection, Aegis Infrared Thermometer, Aegis Plume Evacuator, Aegis Protective Suit, BlissBond, BlissEtch and more

Devices it lists

DeviceProduct codeClassRoleSource
Activator, Ultraviolet, For PolymerizationEBZ2Manufacturer, Manufacturer for exportaccessdata.fda.gov
Agent, Tooth Bonding, ResinKLE2Complaint file establishment, Specification developeraccessdata.fda.gov
Applicator, ResinKXR1Complaint file establishment, Specification developeraccessdata.fda.gov
Clinical Electronic ThermometerSDV2Complaint file establishmentaccessdata.fda.gov
Evacuator, Oral CavityEHZ1Complaint file establishmentaccessdata.fda.gov
Focused Ultrasound For Tissue Heat Or Mechanical Cellular DisruptionOHV2Manufactureraccessdata.fda.gov
Heat Source For Bleaching TeethEEG1Manufactureraccessdata.fda.gov
Lamp, Infrared, Therapeutic HeatingILY2Complaint file establishment, Manufactureraccessdata.fda.gov
Laser Activator For PolymerizationQNF2Complaint file establishment, Manufactureraccessdata.fda.gov
Laser, Dental, Soft TissueNVK2Manufactureraccessdata.fda.gov
Massager, Vacuum, Radio Frequency Induced HeatPBX2Manufactureraccessdata.fda.gov
Microscope, SurgicalEPT1Complaint file establishment, Manufactureraccessdata.fda.gov
Non-Surgical GownOEA1Complaint file establishmentaccessdata.fda.gov
Powder, PorcelainEIH2Repackager or relabeleraccessdata.fda.gov
Powered Laser Surgical InstrumentGEX2Complaint file establishment, Contract manufacturer, Manufactureraccessdata.fda.gov
System, X-Ray, Extraoral Source, DigitalMUH2Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Varnish, CavityLBH2Complaint file establishment, Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 11, 2026K254197Picasso Pro Diode Laser (002-00460)GEXSubstantially EquivalentCAO Group, Inc.accessdata.fda.gov
February 17, 2022K220277Digital Intraoral X-ray SensorMUHSubstantially EquivalentShenzhen Xpectvision Technology Co., Ltd.accessdata.fda.gov
January 7, 2022K213570Dental Zirconia CeramicEIHSubstantially EquivalentAidite (Qinhuangdao) Technology Co., Ltd.accessdata.fda.gov
November 24, 2020K201904Monet Curing LaserQNFSubstantially EquivalentCAO Group, Inc.accessdata.fda.gov
October 28, 2020K201475Ultimate Contour, Ultimate Contour MiniPBXSubstantially EquivalentCAO Group, Inc.accessdata.fda.gov
September 22, 2017K171986Sterling Supreme Diode LaserGEXSubstantially EquivalentCAO Group, Inc.accessdata.fda.gov
December 4, 2015K152175Upcera Dental Zirconia Blank for Aesthetic RestorationEIHSubstantially EquivalentLiaoning Upcera Co., Ltd.accessdata.fda.gov
November 25, 2015K152939Picasso Plus, Picasso Lite PlusGEXSubstantially EquivalentAmd Group, LLCaccessdata.fda.gov
December 18, 2014K141727DENTAL LITHIUM DISILICATE GLASS CERAMIC BLOCK (UP. PRESS SERIES AND UP. CAD SERIES)EIHSubstantially EquivalentLiaoning Upcera Co., Ltd.accessdata.fda.gov
October 22, 2014K141724UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED BLANKEIHSubstantially EquivalentLiaoning Upcera Co., Ltd.accessdata.fda.gov
September 13, 2013K131059PIONEER ELITE DIODE LASERGEXSubstantially EquivalentCAO Group, Inc.accessdata.fda.gov
August 13, 2013K123443PRECISE SHP DIODE LASERGEXSubstantially EquivalentCAO Group, Inc.accessdata.fda.gov
August 13, 2010K100143PILOT DIODE LASER, MODEL 002-00139GEXSubstantially EquivalentCAO Group, Inc.accessdata.fda.gov
October 21, 2009K092616ASCENT BOND UNIVERSAL ADHESIVE SYSTEM, MODELS 006-00029, 006-00030, 006-00044, 006-00045KLESubstantially EquivalentCAO Group, Inc.accessdata.fda.gov
July 23, 2009K091300ASCENT PORCELAIN PRIMER, MODEL 006-00078, 00600079KLESubstantially EquivalentCAO Group, Inc.accessdata.fda.gov
May 25, 2007K070070ASCENT DENTAL CLEANSERLBHSubstantially EquivalentCAO Group, Inc.accessdata.fda.gov
November 14, 2006K062619DENLASER 800 PLUSGEXSubstantially EquivalentCAO Group, Inc.accessdata.fda.gov
June 12, 2006K061341PALMLIGHT 10, MODEL 001-00030EBZSubstantially EquivalentCAO Group, Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
April 15, 201056330Not yet classifiedTerminatedPicasso/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.accessdata.fda.gov

Compare with other makers

Updated March 11, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.