ATOMO DENTAL, INC.

Address:1241 Quarry Lane, Suite 125,Pleasanton,CA,94566,US

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Filters

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

Wrap, Sterilization (FRG) (7) Unit, Operative Dental, Accessories (NRD) (3)

Premarket Exempt

No Yes

Clear

ATOMO - D883AA01141 Catalog Number :

Device Description : ATOMO sterilization pouch 5-1/4"x11"

Device Class :

Duns Number: 088480717

Premarket Exempt : No

Product Code : FRG

Prescription Use : No

Device Count : 200

ATOMO - D883AA01151 Catalog Number :

Device Description : ATOMO sterilization pouch 7-1/2"x14"

Device Class :

Duns Number: 088480717

Premarket Exempt : No

Product Code : FRG

Prescription Use : No

Device Count : 200

ATOMO - D883AA01161 Catalog Number :

Device Description : ATOMO sterilization pouch 10"x15-1/2"

Device Class :

Duns Number: 088480717

Premarket Exempt : No

Product Code : FRG

Prescription Use : No

Device Count : 200

ATOMO - D883AA01171 Catalog Number :

Device Description : ATOMO sterilization pouch 12"x19"

Device Class :

Duns Number: 088480717

Premarket Exempt : No

Product Code : FRG

Prescription Use : No

Device Count : 200

ATOMO - D883AA01181 Catalog Number :

Device Description : ATOMO sterilization pouch 4-1/4"x13"

Device Class :

Duns Number: 088480717

Premarket Exempt : No

Product Code : FRG

Prescription Use : No

Device Count : 200

ATOMO - D883AA01401 Catalog Number :

Device Description : ATOMO SMMS wrap, 12" x 12"

Device Class : 2

Duns Number: 088480717

Premarket Exempt : No

Product Code : FRG

Prescription Use : No

Device Count : 1

ATOMO - D883AA01601 Catalog Number :

Device Description : ATOMO Crepe paper wrap, 12" x 12"

Device Class : 2

Duns Number: 088480717

Premarket Exempt : No

Product Code : FRG

Prescription Use : No

Device Count : 1

ATOMO - D883AA02101 Catalog Number :

Device Description : ATOMO Handpiece Sleeves

Device Class :

Duns Number: 088480717

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 500

ATOMO - D883AA02111 Catalog Number :

Device Description : ATOMO Handpiece Sleeves -2

Device Class :

Duns Number: 088480717

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 500

ATOMO - D883AA02201 Catalog Number :

Device Description : ATOMO Syringe Sleeves

Device Class :

Duns Number: 088480717

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 500

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