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

Pin, Retentive And Splinting, And Accessory Instruments (EBL) (5) Retainer, Matrix (JEP) (4) Cement, Dental (EMA) (1)

Premarket Exempt

No Yes

Clear

Bands, "T" Type - D701BTSCW2 Catalog Number :

Device Description : Stainless-.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 - D701BTSSA2 Catalog Number :

Device Description : Stainless-.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 - D701BTSSN2 Catalog Number :

Device Description : Stainless-.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 - D701BTSSW2 Catalog Number :

Device Description : Stainless-.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

POLYCARB WATERSET - D701CPC2 Catalog Number :

Device Description : WATER ACTIVATED POLYCARBOXYLATE CEMENT

Device Class : 2

Duns Number: 001006089

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Code Rings - D701CR102 Catalog Number :

Device Description : Silicone, medical grade. Box of 100 – mauve

Device Class :

Duns Number: 001006089

Premarket Exempt : Yes

Product Code : EBL

Prescription Use : No

Device Count : 100

Code Rings - D701CR10502 Catalog Number :

Device Description : Silicone, medical grade. Box of 50 – mauve

Device Class :

Duns Number: 001006089

Premarket Exempt : Yes

Product Code : EBL

Prescription Use : No

Device Count : 50

Code Rings - D701CR112 Catalog Number :

Device Description : Silicone, medical grade. Box of 100 – pink

Device Class :

Duns Number: 001006089

Premarket Exempt : Yes

Product Code : EBL

Prescription Use : No

Device Count : 100

Code Rings - D701CR11502 Catalog Number :

Device Description : Silicone, medical grade. Box of 50 – pink

Device Class :

Duns Number: 001006089

Premarket Exempt : Yes

Product Code : EBL

Prescription Use : No

Device Count : 50

Code Rings - D701CR12 Catalog Number :

Device Description : Silicone, medical grade. Box of 100 – white

Device Class :

Duns Number: 001006089

Premarket Exempt : Yes

Product Code : EBL

Prescription Use : No

Device Count : 100

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