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) (4) Mixer, Cement, For Clinical Use (JDZ) (4) Forceps, Articulation Paper (EFK) (2)

Premarket Exempt

No Yes

Clear

Articulating Paper - D701ARPH2 Catalog Number :

Device Description : Double check, 50 microns. Horseshoe, Red & Blue, 72 sheets

Device Class :

Duns Number: 001006089

Premarket Exempt : Yes

Product Code : EFK

Prescription Use : No

Device Count : 72

Articulating Paper - D701ARPS2 Catalog Number :

Device Description : Double check, 50 microns. Straight, Red & Blue, 144 strips

Device Class :

Duns Number: 001006089

Premarket Exempt : Yes

Product Code : EFK

Prescription Use : No

Device Count : 144

Applicator Tips - D701AS202 Catalog Number :

Device Description : Automix tips, clear, straight, tapered – pkg. 20

Device Class :

Duns Number: 001006089

Premarket Exempt : Yes

Product Code : KXR

Prescription Use : No

Device Count : 20

Applicator Tips - D701AS502 Catalog Number :

Device Description : Automix tips, clear, straight, tapered – pkg. 50

Device Class :

Duns Number: 001006089

Premarket Exempt : Yes

Product Code : KXR

Prescription Use : No

Device Count : 50

Mini-Bowls - D701BMA2 Catalog Number :

Device Description : Non-stick silicone for acrylics, with suction base. Assorted (Set: 2 Small, 1 Me Non-stick silicone for acrylics, with suction base. Assorted (Set: 2 Small, 1 Medium, 1 Large)

Device Class :

Duns Number: 001006089

Premarket Exempt : Yes

Product Code : JDZ

Prescription Use : No

Device Count : 4

Mini-Bowls - D701BML2 Catalog Number :

Device Description : Non-stick silicone for acrylics, with suction base. Large, 80cc (Single) (2 1/4” Non-stick silicone for acrylics, with suction base. Large, 80cc (Single) (2 1/4” diameter).

Device Class : 1

Duns Number: 001006089

Premarket Exempt : Yes

Product Code : JDZ

Prescription Use : No

Device Count : 1

Mini-Bowls - D701BMM22 Catalog Number :

Device Description : Non-stick silicone for acrylics, with suction base. Medium, 30 cc (Set of 2) (1 Non-stick silicone for acrylics, with suction base. Medium, 30 cc (Set of 2) (1 5/8” diameter)

Device Class :

Duns Number: 001006089

Premarket Exempt : Yes

Product Code : JDZ

Prescription Use : No

Device Count : 2

Mini-Bowls - D701BMS32 Catalog Number :

Device Description : Non-stick silicone for acrylics, with suction base. Small, 8cc (Set of 3) (1” diameter)

Device Class :

Duns Number: 001006089

Premarket Exempt : Yes

Product Code : JDZ

Prescription Use : No

Device Count : 3

Brush Tips and Handles - D701BR2 Catalog Number :

Device Description : Brush Tips, 24 mm length, bag of 100

Device Class :

Duns Number: 001006089

Premarket Exempt : Yes

Product Code : KXR

Prescription Use : No

Device Count : 100

Brush Tips and Handles - D701BR22 Catalog Number :

Device Description : Long Handle Brushes, 2 1/8 length, bag of 50

Device Class :

Duns Number: 001006089

Premarket Exempt : Yes

Product Code : KXR

Prescription Use : No

Device Count : 50

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