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

Protector, Dental (BRW) (5) Mouthpiece, Saliva Ejector (DYN) (3) Liner, Cavity, Calcium Hydroxide (EJK) (1) Retractor, All Types (EIG) (1)

Premarket Exempt

No Yes

Clear

KöR - 00850362007106 Catalog Number : 10-1018

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 - 00850362007113 Catalog Number : 80-1006

Device Description : Dental cheek retractor and suction tip.

Device Class : 1

Duns Number: 005479970

Premarket Exempt : Yes

Product Code : BRW, DYN

Prescription Use : Yes

Device Count : 1

KöR - 00850362007120 Catalog Number : 80-1013

Device Description : Dental retractor and suction tip.

Device Class : 1

Duns Number: 005479970

Premarket Exempt : No

Product Code : BRW, DYN

Prescription Use : Yes

Device Count : 1

KöR - 00850362007137 Catalog Number : 80-1032

Device Description : Dental dam.

Device Class : 1

Duns Number: 005479970

Premarket Exempt : Yes

Product Code : EIG

Prescription Use : Yes

Device Count : 1

KöR - 00850362007144 Catalog Number : 80-1029

Device Description : Dental Suction Tip

Device Class : 1

Duns Number: 005479970

Premarket Exempt : Yes

Product Code : DYN

Prescription Use : Yes

Device Count : 1

KöR - 00850362007151 Catalog Number : 80-1059

Device Description : Dental cheek retractor.

Device Class : 1

Duns Number: 005479970

Premarket Exempt : Yes

Product Code : BRW

Prescription Use : Yes

Device Count : 1

KöR - 00850362007168 Catalog Number : 80-1060

Device Description : Dental cheek retractor.

Device Class : 1

Duns Number: 005479970

Premarket Exempt : Yes

Product Code : BRW

Prescription Use : Yes

Device Count : 1

KöR - 00850362007175 Catalog Number : 80-1061

Device Description : Dental cheek retractor.

Device Class : 1

Duns Number: 005479970

Premarket Exempt : Yes

Product Code : BRW

Prescription Use : Yes

Device Count : 1

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