Denplus Inc

Address:333-M Chemin du Tremblay,Boucherville Quebec,CA

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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

Resin, Denture, Relining, Repairing, Rebasing (EBI) (9) Material, Impression Tray, Resin (EBH) (1)

Premarket Exempt

No Yes

Clear

DP-Tray-F - D8451122200 Catalog Number : 1122200

Device Description : DP-Tray-F, Fast Liquid, 1 l

Device Class : 1

Duns Number: 202016064

Premarket Exempt : Yes

Product Code : EBH

Prescription Use : No

Device Count : 1

HIGH-WAVE - D8451141102 Catalog Number : 1141102

Device Description : HIGH-WAVE, LPL, 454 g

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

HIGH-WAVE - D8451141107 Catalog Number : 1141107

Device Description : HIGH-WAVE, MDP, 454 g

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

HIGH-WAVE - D8451141116 Catalog Number : 1141116

Device Description : HIGH-WAVE, ORI, 454 g

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

HIGH-WAVE - D8451141117 Catalog Number : 1141117

Device Description : HIGH-WAVE, VIR, 454 g

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

HIGH-WAVE - D8451141202 Catalog Number : 1141202

Device Description : HIGH-WAVE, LPL, 2.3 kg

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

HIGH-WAVE - D8451141207 Catalog Number : 1141207

Device Description : HIGH-WAVE, MDP, 2.3 kg

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

HIGH-WAVE - D8451141216 Catalog Number : 1141216

Device Description : HIGH-WAVE, ORI, 2.3 kg

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

HIGH-WAVE - D8451141217 Catalog Number : 1141217

Device Description : HIGH-WAVE, VIR, 2.3 kg

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

HIGH-WAVE - D8451141302 Catalog Number : 1141302

Device Description : HIGH-WAVE, LPL, 11.3 kg

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

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