PULPDENT CORPORATION

Address:80 Oakland St,Watertown,MA,02472,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

Applicator, Resin (KXR) (10)

Premarket Exempt

No Yes

Clear

Applicator Tips - D70130F502 Catalog Number :

Device Description : Orange, 30 ga x 1”, straight tips – pkg. 50

Device Class : 1

Duns Number: 001006089

Premarket Exempt : Yes

Product Code : KXR

Prescription Use : No

Device Count : 50

Applicator Tips - D701A202 Catalog Number :

Device Description : Automix syringe tips – pkg. 20

Device Class :

Duns Number: 001006089

Premarket Exempt : Yes

Product Code : KXR

Prescription Use : No

Device Count : 20

Applicator Tips - D701A20N12 Catalog Number :

Device Description : Automix tips, clear, with bendable 20-gaude metal cannula – pkg. 20

Device Class :

Duns Number: 001006089

Premarket Exempt : Yes

Product Code : KXR

Prescription Use : No

Device Count : 20

Applicator Tips - D701A502 Catalog Number :

Device Description : Automix syringe tips – pkg. 50

Device Class :

Duns Number: 001006089

Premarket Exempt : Yes

Product Code : KXR

Prescription Use : No

Device Count : 50

Applicator Tips - D701A50N12 Catalog Number :

Device Description : Automix tips, clear, with bendable 20-gaude metal cannula – pkg. 50

Device Class :

Duns Number: 001006089

Premarket Exempt : Yes

Product Code : KXR

Prescription Use : No

Device Count : 50

Applicator Tips - D701AD20R2 Catalog Number :

Device Description : Automix tips, clear + long, narrow intraoral tips (IOT) – pkg. 20

Device Class :

Duns Number: 001006089

Premarket Exempt : Yes

Product Code : KXR

Prescription Use : No

Device Count : 20

Applicator Tips - D701AD20T2 Catalog Number :

Device Description : Automix tips, clear + short intraoral tips (IOT) – pkg. 20

Device Class :

Duns Number: 001006089

Premarket Exempt : Yes

Product Code : KXR

Prescription Use : No

Device Count : 20

Applicator Tips - D701AD50R2 Catalog Number :

Device Description : Automix tips, clear + long, narrow intraoral tips (IOT) – pkg. 50

Device Class :

Duns Number: 001006089

Premarket Exempt : Yes

Product Code : KXR

Prescription Use : No

Device Count : 50

Applicator Tips - D701AD50T2 Catalog Number :

Device Description : Automix tips, clear + short intraoral tips (IOT) – pkg. 50

Device Class :

Duns Number: 001006089

Premarket Exempt : Yes

Product Code : KXR

Prescription Use : No

Device Count : 50

Dispensing Straws - D701APS1002 Catalog Number :

Device Description : Package of 100

Device Class :

Duns Number: 001006089

Premarket Exempt : Yes

Product Code : KXR

Prescription Use : No

Device Count : 100

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