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

Mouthpiece, Saliva Ejector (DYN) (6) Tray, Impression, Preformed (EHY) (4)

Premarket Exempt

No Yes

Clear

ATOMO - D883AA04201 Catalog Number :

Device Description : ATOMO High-Volume Evacuator Tip

Device Class :

Duns Number: 088480717

Premarket Exempt : Yes

Product Code : DYN

Prescription Use : No

Device Count : 100

ATOMO - D883AA04251 Catalog Number :

Device Description : ATOMO Surgical Aspirator Tips, Small

Device Class :

Duns Number: 088480717

Premarket Exempt : Yes

Product Code : DYN

Prescription Use : No

Device Count : 25

ATOMO - D883AA04261 Catalog Number :

Device Description : ATOMO Surgical Aspirator Tips, Standard

Device Class :

Duns Number: 088480717

Premarket Exempt : Yes

Product Code : DYN

Prescription Use : No

Device Count : 25

ATOMO - D883AA04271 Catalog Number :

Device Description : ATOMO Surgical Aspirator Tips, Large

Device Class :

Duns Number: 088480717

Premarket Exempt : Yes

Product Code : DYN

Prescription Use : No

Device Count : 25

ATOMO - D883AA04301 Catalog Number :

Device Description : ATOMO saliva ejector, blue

Device Class :

Duns Number: 088480717

Premarket Exempt : Yes

Product Code : DYN

Prescription Use : No

Device Count : 100

ATOMO - D883AA04311 Catalog Number :

Device Description : ATOMO saliva ejector, white

Device Class :

Duns Number: 088480717

Premarket Exempt : Yes

Product Code : DYN

Prescription Use : No

Device Count : 100

ATOMO - D883AA08011 Catalog Number :

Device Description : ATOMO Disposable Impression Trays, Large Upper

Device Class :

Duns Number: 088480717

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 10

ATOMO - D883AA08021 Catalog Number :

Device Description : ATOMO Disposable Impression Trays, Large Lower

Device Class :

Duns Number: 088480717

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 10

ATOMO - D883AA08031 Catalog Number :

Device Description : ATOMO Disposable Impression Trays, Medium Upper

Device Class :

Duns Number: 088480717

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 10

ATOMO - D883AA08041 Catalog Number :

Device Description : ATOMO Disposable Impression Trays, Medium Lower

Device Class :

Duns Number: 088480717

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 10

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