Envisiontec GmbH

Address:Bruesseler Strasse 51,Gladbeck North Rhine-Westphalia,DE

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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

Additively Manufactured, Preformed, Resin Denture Tooth (PZY) (5) Mouthguard, Prescription (MQC) (2) Accessories, Implant, Dental, Endosseous (NDP) (1) Applicator, Absorbent Tipped, Non-Sterile (KXF) (1) Material, Impression Tray, Resin (EBH) (1)

Premarket Exempt

No Yes

Clear

E-Guard Blue - 04260683220041 Catalog Number : RES-01-3121

Device Description : E-Guard Blue is a light-curing material for the additive manufacturing of indivi

Device Class : U

Duns Number: 332025159

Premarket Exempt : No

Product Code : MQC

Prescription Use : Yes

Device Count : 1

E-Guard - 04260683220102 Catalog Number : RES-01-3113

Device Description : E-Guard is a light-curing material for the additive manufacturing of individual

Device Class : U

Duns Number: 332025159

Premarket Exempt : No

Product Code : MQC

Prescription Use : Yes

Device Count : 1

E-Guide - 04260683220133 Catalog Number : RES-01-3012

Device Description : E-Guide is a light-curing material for the additive manufacturing of individual

Device Class : 1

Duns Number: 332025159

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

E-Guide Soft - 04260683220140 Catalog Number : RES-01-3115

Device Description : E-Guide Soft is a light-curing material for the additive manufacturing of nasoph

Device Class : 1

Duns Number: 332025159

Premarket Exempt : Yes

Product Code : KXF

Prescription Use : Yes

Device Count : 1

E-Tray - 04260683220171 Catalog Number : RES-01-3114

Device Description : E-Tray is a light-curing material for the additive manufacturing of individual d

Device Class : 1

Duns Number: 332025159

Premarket Exempt : Yes

Product Code : EBH

Prescription Use : Yes

Device Count : 1

Flexcera Smile A1 - 04260683220287 Catalog Number : RES-01-3134

Device Description : Flexcera Smile is a light-curing material for the additive manufacturing of arti

Device Class : 2

Duns Number: 332025159

Premarket Exempt : Yes

Product Code : PZY

Prescription Use : Yes

Device Count : 1

Flexcera Smile A2 - 04260683220294 Catalog Number : RES-01-3135

Device Description : Flexcera Smile is a light-curing material for the additive manufacturing of arti

Device Class : 2

Duns Number: 332025159

Premarket Exempt : Yes

Product Code : PZY

Prescription Use : Yes

Device Count : 1

Flexcera Smile A3 - 04260683220300 Catalog Number : RES-01-3136

Device Description : Flexcera Smile is a light-curing material for the additive manufacturing of arti

Device Class : 2

Duns Number: 332025159

Premarket Exempt : Yes

Product Code : PZY

Prescription Use : Yes

Device Count : 1

Flexcera Smile A3.5 - 04260683220317 Catalog Number : RES-01-3137

Device Description : Flexcera Smile is a light-curing material for the additive manufacturing of arti

Device Class : 2

Duns Number: 332025159

Premarket Exempt : Yes

Product Code : PZY

Prescription Use : Yes

Device Count : 1

Flexcera Smile B1 - 04260683220324 Catalog Number : RES-01-3138

Device Description : Flexcera Smile is a light-curing material for the additive manufacturing of arti

Device Class : 2

Duns Number: 332025159

Premarket Exempt : Yes

Product Code : PZY

Prescription Use : Yes

Device Count : 1

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