Manufacturer registered with FDA
CAO Group, Inc.
West Jordan, UT, United States. Lists 9 dental device types with FDA across 2 registered establishments, and holds 13 510(k) clearances as applicant.
- Device types listed
- 9
- Brands and models
- 17
- 510(k) clearances
- 132002–2020
- Markets registered in
- 419 registrations outside the US
- Establishments
- 2China, United States
510(k) clearances per year, 2000–2026
Registered in 4 markets
Where regulators' registries name CAO Group, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | CAO Group, Inc. | 13 clearances | 2002–2020 | Below |
| European Union | EUDAMED | Manufacturer | CAO Group, Inc. | 15 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | CAO Group, Inc. | 3 | — | Pure Global AI |
| China | NMPA | Registration holder | 西尔欧集团CAO Group,Inc. | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What CAO Group, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Lister | Upcera Lithium Disilicate Glass Ceramic Block | 2025 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | BlissBondBlissEtchFastFix | 2009 |
| Cavity VarnishLBH · Class 2 | Sealants & varnishes | Maker | BlissBondBlissEtchLEAP Cavity Cleansing Solution | 2007 |
| Heat Source for Bleaching TeethEEG · Class 1 | Teeth whitening lights | Maker | Picasso Pro Diode Laser | 2026 |
| Resin ApplicatorKXR · Class 1 | — | Maker | FE Scrub TipLiqua TipVisco Tip | 2018 |
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Maker | ASCENT OLXASCENT PXPALMLIGHT 10, MODEL: 001-00030SMARTLITE MAX | 2005 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Lister | Aegis Plume Evacuator | 2020 |
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Lister | Acuity Direct X-Ray Photon Detection | 2024 |
| Laser Activator for PolymerizationQNF · Class 2 | — | Maker | — | 2020 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names CAO Group, Inc. as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 24 Nov 2020 | K201904 | Monet Curing Laser | QNF Laser Activator for Polymerization |
| 31 Dec 2015 | K150585 | Ascent 3D | EBZ Ultraviolet Activator for Polymerization |
| 6 Jan 2011 | K103160 | NUPRO MODEL 13016901 | LBH Cavity Varnish |
| 23 Sep 2010 | K100540 | ASCENT F-COAT MODEL: 006-00097 | LBH Cavity Varnish |
| 21 Oct 2009 | K092616 | ASCENT BOND UNIVERSAL ADHESIVE SYSTEM, MODELS 006-00029, 006-00030, 006-00044, 006-00045 | KLE Resin Tooth Bonding Agent |
| 23 Jul 2009 | K091300 | ASCENT PORCELAIN PRIMER, MODEL 006-00078, 00600079 | KLE Resin Tooth Bonding Agent |
| 25 May 2007 | K070070 | ASCENT DENTAL CLEANSER | LBH Cavity Varnish |
| 26 Apr 2007 | K070413 | ASCENT UNIVERSAL ADHESIVE, MODEL 006-00028 | KLE Resin Tooth Bonding Agent |
| 6 Nov 2006 | K062886 | ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019 | EBC Pit and Fissure Sealant and Conditioner |
| 12 Jun 2006 | K061341 | PALMLIGHT 10, MODEL 001-00030 | EBZ Ultraviolet Activator for Polymerization |
| 20 Dec 2005 | K053089 | ASCENT PIT & FISSURE SEALANT | EBC Pit and Fissure Sealant and Conditioner |
| 8 Nov 2004 | K041392 | SONX 35 ULTRASONIC BLEACHING SYSTEM; SONIWHITE ULTRA SONIC, MODEL QUICK WHITE US | EEG Heat Source for Bleaching Teeth |
| 27 Aug 2002 | K020057 | PALMLIGHT | EBZ Ultraviolet Activator for Polymerization |
Also lists devices cleared under other names
CAO Group, Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Liaoning Upcera Co., Ltd (3), Shenzhen Xpectvision Technology Co., Ltd. (1), Aidite (Qinhuangdao) Technology Co., Ltd (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 17 Feb 2022 | K220277 | Digital Intraoral X-ray Sensor | Shenzhen Xpectvision Technology Co., Ltd. | MUH Digital Extraoral Source X-Ray System |
| 7 Jan 2022 | K213570 | Dental Zirconia Ceramic | Aidite (Qinhuangdao) Technology Co., Ltd | EIH Porcelain Powder |
| 4 Dec 2015 | K152175 | Upcera Dental Zirconia Blank for Aesthetic Restoration | Liaoning Upcera Co., Ltd | EIH Porcelain Powder |
| 18 Dec 2014 | K141727 | DENTAL LITHIUM DISILICATE GLASS CERAMIC BLOCK (UP. PRESS SERIES AND UP. CAD SERIES) | Liaoning Upcera Co., Ltd | EIH Porcelain Powder |
| 22 Oct 2014 | K141724 | UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED BLANK | Liaoning Upcera Co., Ltd | EIH Porcelain Powder |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| CAO (CHINA) MEDICAL EQUIPMENT COMPANY, LIMITEDFDA reg. 3004475754 | LANGFANG, HEBEI, China | Contract manufacturer, Manufacturer |
| CAO GROUP, INC.FDA reg. 1725006 | W Jordan, UT, United States | Complaint file establishment, Manufacturer for export, Manufacturer, Repacker / relabeler, Specification developer |
Other names on FDA records
Cao (China) Medical Equipment Company, Limited
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9043755). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.