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

Retainer, Matrix (JEP) (8) Applicator, Resin (KXR) (2)

Premarket Exempt

No Yes

Clear

Brush Tips and Handles - D701BR2L2 Catalog Number :

Device Description : Long Handle Brushes, 2 1/8 length, bag of 400

Device Class :

Duns Number: 001006089

Premarket Exempt : Yes

Product Code : KXR

Prescription Use : No

Device Count : 400

Brush Tips and Handles - D701BRL2 Catalog Number :

Device Description : Brush Tips, 24 mm length, bag of 500 + 2 Handles

Device Class : 1

Duns Number: 001006089

Premarket Exempt : Yes

Product Code : KXR

Prescription Use : No

Device Count : 1

Bands, "T" Type - D701BTBCA2 Catalog Number :

Device Description : Brass-.002/.05mm Thick (Box of 100). Curved – Assorted

Device Class :

Duns Number: 001006089

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : No

Device Count : 100

Bands, "T" Type - D701BTBCN2 Catalog Number :

Device Description : Brass-.002/.05mm Thick (Box of 100). Curved – Narrow

Device Class :

Duns Number: 001006089

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : No

Device Count : 100

Bands, "T" Type - D701BTBCW2 Catalog Number :

Device Description : Brass-.002/.05mm Thick (Box of 100). Curved – Wide

Device Class :

Duns Number: 001006089

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : No

Device Count : 100

Bands, "T" Type - D701BTBSA2 Catalog Number :

Device Description : Brass-.002/.05mm Thick (Box of 100). Straight – Assorted

Device Class :

Duns Number: 001006089

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : No

Device Count : 100

Bands, "T" Type - D701BTBSN2 Catalog Number :

Device Description : Brass-.002"/.05mm Thick (box of 100). Straight – Narrow (5/32”)

Device Class :

Duns Number: 001006089

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : No

Device Count : 100

Bands, "T" Type - D701BTBSW2 Catalog Number :

Device Description : Brass-.002/.05mm Thick (Box of 100). Straight – Wide (1/4”)

Device Class :

Duns Number: 001006089

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : No

Device Count : 100

Bands, "T" Type - D701BTSCA2 Catalog Number :

Device Description : Stainless-.002/.05mm Thick (Box of 100). Curved – Assorted

Device Class :

Duns Number: 001006089

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : No

Device Count : 100

Bands, "T" Type - D701BTSCN2 Catalog Number :

Device Description : Stainless-.002/.05mm Thick (Box of 100). Curved – Narrow

Device Class :

Duns Number: 001006089

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : No

Device Count : 100

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