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

Cement, Dental (EMA) (6) Material, Tooth Shade, Resin (EBF) (4)

Premarket Exempt

No Yes

Clear

Activa Presto - D701VPF1A42 Catalog Number :

Device Description : 2 x 1.2 mL syringe + 20 tips, shade A4

Device Class : 2

Duns Number: 001006089

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Activa Presto - D701VPF1A62 Catalog Number :

Device Description : 2 x 1.2 mL syringe + 20 tips, shade A6

Device Class : 2

Duns Number: 001006089

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Activa Presto - D701VPF1B12 Catalog Number :

Device Description : 2 x 1.2 mL syringe + 20 tips, shade B1

Device Class : 2

Duns Number: 001006089

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Activa Presto - D701VPF1BW2 Catalog Number :

Device Description : 2 x 1.2 mL syringe + 20 tips, shade bleach white

Device Class : 2

Duns Number: 001006089

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

ACTIVA BioACTIVE-RESTORATIVE - D701VR1A12 Catalog Number :

Device Description : ACTIVA REST SINGLE A1 SHADE 1 X 5 ml/8gm syringe + 20 tips

Device Class : 2

Duns Number: 001006089

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

ACTIVA BioACTIVE-RESTORATIVE - D701VR1A22 Catalog Number :

Device Description : ACTIVA REST SINGLE A2 SHADE 1 X 5 ml/8gm syringe + 20 tips

Device Class : 2

Duns Number: 001006089

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

ACTIVA BioACTIVE-RESTORATIVE - D701VR1A32 Catalog Number :

Device Description : ACTIVA REST SINGLE A3 SHADE 1 X 5 ml/8gm syringe + 20 tips

Device Class : 2

Duns Number: 001006089

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

ACTIVA BioACTIVE-RESTORATIVE - D701VR1A352 Catalog Number :

Device Description : ACTIVA REST SINGLE A3.5 SHADE 1 X 5 ml/8gm syringe + 20 tips

Device Class : 2

Duns Number: 001006089

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

ACTIVA BioACTIVE-RESTORATIVE - D701VR2A12 Catalog Number :

Device Description : ACTIVA REST 2-PACK A1 SHADE 2 X 5 ml/8gm syringe + 40 tips

Device Class : 2

Duns Number: 001006089

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

ACTIVA BioACTIVE-RESTORATIVE - D701VR2A22 Catalog Number :

Device Description : ACTIVA REST 2-PACK A2 SHADE 2 X 5 ml/8gm syringe + 40 tips

Device Class : 2

Duns Number: 001006089

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

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