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

Laser Activator For Polymerization (QNF) (5) Non-Surgical Isolation Gown (OEA) (3) Evacuator, Oral Cavity (EHZ) (2)

Premarket Exempt

Yes No

Clear

Aegis Personal Protective Suit - 00872320005511 Catalog Number :

Device Description : Reusable polyester protective suit. Extra, extra, extra, extra, extra, extra large size.

Device Class : 1

Duns Number: 102422578

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 1

Aegis Personal Protective Suit - 00872320005528 Catalog Number :

Device Description : Single use 2-piece protective suit. Extra, extra, extra, extra, extra, extra large size.

Device Class : 1

Duns Number: 102422578

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 1

Aegis Personal Protective Suit - 00872320005535 Catalog Number :

Device Description : Reusable non-woven poly protective suit. Extra, extra, extra, extra, extra, extr Reusable non-woven poly protective suit. Extra, extra, extra, extra, extra, extra large size.

Device Class : 1

Duns Number: 102422578

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 1

Aegis Aerosol VacStation Small Inlet Collector - 00872320005603 Catalog Number :

Device Description : Replacement small square inlet collector for the Aegis Aerosol VacStation.

Device Class : 1

Duns Number: 102422578

Premarket Exempt : Yes

Product Code : EHZ

Prescription Use : Yes

Device Count : 1

Monet Curing Laser - 00872320005610 Catalog Number :

Device Description : Handheld laser device used for polymerizing dental materials.

Device Class : 2

Duns Number: 102422578

Premarket Exempt : No

Product Code : QNF

Prescription Use : Yes

Device Count : 1

Monet Curing Laser Battery Pack - 00872320005627 Catalog Number :

Device Description : Replacement battery pack for use with the Monet Curing Laser.

Device Class : 2

Duns Number: 102422578

Premarket Exempt : No

Product Code : QNF

Prescription Use : Yes

Device Count : 1

Monet Curing Laser Large Glasses - 00872320005634 Catalog Number :

Device Description : Large laser protective glasses for use with the Monet Curing Laser.

Device Class : 2

Duns Number: 102422578

Premarket Exempt : No

Product Code : QNF

Prescription Use : Yes

Device Count : 1

Monet Curing Laser Small Glasses - 00872320005641 Catalog Number :

Device Description : Small laser protective glasses for use with the Monet Curing Laser.

Device Class : 2

Duns Number: 102422578

Premarket Exempt : No

Product Code : QNF

Prescription Use : Yes

Device Count : 1

Monet Curing Laser Charging Stand - 00872320005665 Catalog Number :

Device Description : Replacement charging stand for use with the Monet Curing Laser.

Device Class : 2

Duns Number: 102422578

Premarket Exempt : No

Product Code : QNF

Prescription Use : Yes

Device Count : 1

Aegis Air Filtration System - 00872320005696 Catalog Number :

Device Description : Portable air filtration station to remove particulates and contaminants from the Portable air filtration station to remove particulates and contaminants from the air within an enclosed room or space.

Device Class : 1

Duns Number: 102422578

Premarket Exempt : Yes

Product Code : EHZ

Prescription Use : Yes

Device Count : 1

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