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) (10)

Premarket Exempt

No Yes

Clear

POUR-PLUS - D8451151116 Catalog Number : 1151116

Device Description : POUR-PLUS, ORI, 454 g

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

POUR-PLUS - D8451151200 Catalog Number : 1151200

Device Description : POUR-PLUS, CLR, 2.3 kg

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

POUR-PLUS - D8451151202 Catalog Number : 1151202

Device Description : POUR-PLUS, LPL, 2.3 kg

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

POUR-PLUS - D8451151205 Catalog Number : 1151205

Device Description : POUR-PLUS, LPI, 2.3 kg

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

POUR-PLUS - D8451151207 Catalog Number : 1151207

Device Description : POUR-PLUS, MDP, 2.3 kg

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

POUR-PLUS - D8451151216 Catalog Number : 1151216

Device Description : POUR-PLUS, ORI, 2.3 kg

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

POUR-PLUS - D8451151300 Catalog Number : 1151300

Device Description : POUR-PLUS, CLR, 11.3 kg

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

POUR-PLUS - D8451151302 Catalog Number : 1151302

Device Description : POUR-PLUS, LPL, 11.3 kg

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

POUR-PLUS - D8451151305 Catalog Number : 1151305

Device Description : POUR-PLUS, LPI, 11.3 kg

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

POUR-PLUS - D8451151305SF0 Catalog Number : 1151305SF

Device Description : POUR-PLUS, LPI, WITHOUT FIBERS, 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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