EVOLVE DENTAL TECHNOLOGIES, INC.

Address:5 Vanderbilt,Irvine,CA,92618,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

Material, Impression (ELW) (5) Agent, Tooth Bonding, Resin (KLE) (3) Liner, Cavity, Calcium Hydroxide (EJK) (2)

Premarket Exempt

No Yes

Clear

KöR - 00850362007007 Catalog Number : 10-1013

Device Description : Vinyl Polysiloxane Putty - Fast set impression material.

Device Class : 2

Duns Number: 005479970

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

KöR - 00850362007014 Catalog Number : 10-1014

Device Description : Vinyl Polysiloxane Putty - Regular set impression material.

Device Class : 2

Duns Number: 005479970

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

KöR - 00850362007021 Catalog Number : 10-1008

Device Description : KöR Impression Tray Adhesive is an adhesive developed specifically for durable a KöR Impression Tray Adhesive is an adhesive developed specifically for durable adhesion of addition curing vinyl silicone impression materials to disposable impression trays and avoids lifting of the impression material from the tray when taking the impression out of the mouth.

Device Class : 2

Duns Number: 005479970

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

KöR - 00850362007038 Catalog Number : 10-1015

Device Description : Impression Material - Super-Hydrophilic Vinyl Polysiloxane Light Body Wash

Device Class : 2

Duns Number: 005479970

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

KöR - 00850362007045 Catalog Number : 10-1004

Device Description : Impression Material - Super-Hydrophilic Vinyl Polysiloxane, Fast Set

Device Class : 2

Duns Number: 005479970

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

KöR - 00850362007052 Catalog Number : 10-1010

Device Description : KöR Desensitizer-10ml

Device Class : 2

Duns Number: 005479970

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

KöR - 00850362007069 Catalog Number : 10-1011

Device Description : KöR Teeth Desensitizer - 2.5ml

Device Class : 2

Duns Number: 005479970

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

KöR - 00850362007076 Catalog Number : 10-1012

Device Description : KöR Teeth Desensitizer - 5ml

Device Class : 2

Duns Number: 005479970

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

KöR - 00850362007083 Catalog Number : 10-1017

Device Description : Tooth desensitizer for reduction or elimination of teeth sensitivity during teet Tooth desensitizer for reduction or elimination of teeth sensitivity during teeth whitening and all other desensitizing needs.

Device Class : 2

Duns Number: 005479970

Premarket Exempt : No

Product Code : EJK

Prescription Use : Yes

Device Count : 1

KöR - 00850362007090 Catalog Number : 10-1016

Device Class : 2

Duns Number: 005479970

Premarket Exempt : No

Product Code : EJK

Prescription Use : Yes

Device Count : 1

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