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

HIGH-WAVE - D8451141307 Catalog Number : 1141307

Device Description : HIGH-WAVE, MDP, 11.3 kg

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

HIGH-WAVE - D8451141309 Catalog Number : 1141309

Device Description : HIGH-WAVE, CUSTOM, 11.3 kg

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

HIGH-WAVE - D8451141316 Catalog Number : 1141316

Device Description : HIGH-WAVE, ORI, 11.3 kg

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

HIGH-WAVE - D8451141317 Catalog Number : 1141317

Device Description : HIGH-WAVE, VIR, 11.3 kg

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

HIGH-WAVE - D8451142100 Catalog Number : 1142100

Device Description : HIGH-WAVE LIQUID, 250 ml

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

HIGH-WAVE - D8451142200 Catalog Number : 1142200

Device Description : HIGH-WAVE LIQUID, 1 L

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

POUR-PLUS - D8451151100 Catalog Number : 1151100

Device Description : POUR-PLUS, CLR, 454 g

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

POUR-PLUS - D8451151102 Catalog Number : 1151102

Device Description : POUR-PLUS, LPL, 454 g

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

POUR-PLUS - D8451151105 Catalog Number : 1151105

Device Description : POUR-PLUS, LPI, 454 g

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

POUR-PLUS - D8451151107 Catalog Number : 1151107

Device Description : POUR-PLUS, MDP, 454 g

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

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