CAO GROUP, INC.

Address:4628 WEST SKYHAWK DRIVE,WEST JORDAN,UT,84084,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Powered Laser Surgical Instrument (GEX) (5) Agent, Tooth Bonding, Resin (KLE) (3) Activator, Ultraviolet, For Polymerization (EBZ) (2) Varnish, Cavity (LBH) (1)

Premarket Exempt

No Yes

Clear

BlissBond Intro Kit - 00872320000127 Catalog Number : 006-00044

Device Description : Single-component dental resin adhesive.

Device Class :

Duns Number: 102422578

Premarket Exempt : No

Product Code : LBH, KLE

Prescription Use : Yes

Device Count : 2

BlissEtch Intro Kit - 00872320000141 Catalog Number : 006-00029

Device Description : Phosphoric acid free dental tooth etchant.

Device Class :

Duns Number: 102422578

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 3

FastFix Porcelain Primer Kit - 00872320000509 Catalog Number : 006-00078

Device Description : 1-Step Silane primer applied to porcelain dental restorations for bonding to teeth.

Device Class :

Duns Number: 102422578

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 3

Pioneer Elite Ergonomic Handpiece Sleeve - 00872320000868 Catalog Number :

Device Description : Removable surgical handpiece sleeve for the Pioneer Elite Diode Laser.

Device Class :

Duns Number: 102422578

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Precise LTM Diode Laser - 00872320001360 Catalog Number : 002-00176

Device Description : Diode laser for dental soft tissue treatments and procedures.

Device Class : 2

Duns Number: 102422578

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Precise LTM Handpiece - 00872320001391 Catalog Number : 002-00203

Device Description : Replacement handpiece for the Precise LTM.

Device Class :

Duns Number: 102422578

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Precise LTM Fiber Cartridge - 00872320001438 Catalog Number : 002-00206

Device Description : Replacement fiber cartridge for the Precise LTM Diode Laser.

Device Class : 2

Duns Number: 102422578

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Ascent PX Replacement Wand - 00872320001469 Catalog Number : 001-00052

Device Description : Replacement wand (light probe) for the Ascent PX curing light.

Device Class : 2

Duns Number: 102422578

Premarket Exempt : No

Product Code : EBZ

Prescription Use : Yes

Device Count : 1

Ascent PX Charging Station - 00872320001476 Catalog Number : 001-00051

Device Description : Recharging station for use with the Ascent PX Dental Curing Light

Device Class : 2

Duns Number: 102422578

Premarket Exempt : No

Product Code : EBZ

Prescription Use : Yes

Device Count : 1

Precise SHP Handpiece Sleeve - 00872320001742 Catalog Number : 002-00226

Device Description : Removeable handpiece sleeve for use with the Precise SHP Diode Laser.

Device Class : 2

Duns Number: 102422578

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

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