3D DENTAL DESIGNS AND DEVELOPMENT, LLC

Address:16781 chagrin blvd,Shaker Heights,OH,44120,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

Crown And Bridge, Temporary, Resin (EBG) (3) Material, Impression (ELW) (3) Agent, Tooth Bonding, Resin (KLE) (2) Varnish, Cavity (LBH) (2)

Premarket Exempt

No Yes

Clear

MIMIC-3D Dental - 00817169020110 Catalog Number :

Device Description : MIMIC VPS PUTTY REGULAR SET

Device Class : 2

Duns Number: 080194935

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

MIMIC-3D Dental - 00817169020127 Catalog Number :

Device Description : VPS Vinyl Polysiloxane Impression Material 2/Pk Medium Body FS

Device Class : 2

Duns Number: 080194935

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

MIMIC-3D Dental - 00817169020134 Catalog Number :

Device Description : VPS Vinyl Polysiloxane Impression Material 2/Pk Medium Body RS

Device Class : 2

Duns Number: 080194935

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

MIMIC-3D Dental - 00817169020141 Catalog Number :

Device Description : TEMPORARY CROWN & BRIDGE MATERIAL 76GM 10:1 5 TIPS A1/B1

Device Class : 2

Duns Number: 080194935

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

MIMIC-3D Dental - 00817169020158 Catalog Number :

Device Description : TEMPORARY CROWN & BRIDGE MATERIAL 76GM 10:1 5 TIPS A2

Device Class : 2

Duns Number: 080194935

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

MIMIC-3D Dental - 00817169020165 Catalog Number :

Device Description : TEMPORARY CROWN & BRIDGE MATERIAL 76GM 10:1 5 TIPS A3

Device Class : 2

Duns Number: 080194935

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

3D Dental - Dream - 00817169020172 Catalog Number :

Device Description : DREAM FLUORIDE VARNISH BUBBLE GUM .40 ML BOX/50

Device Class : 2

Duns Number: 080194935

Premarket Exempt : No

Product Code : LBH

Prescription Use : Yes

Device Count : 1

3D Dental - Dream - 00817169020189 Catalog Number :

Device Description : DREAM FLUORIDE VARNISH SPEARMINT .40 ML BOX/50

Device Class : 2

Duns Number: 080194935

Premarket Exempt : Yes

Product Code : LBH

Prescription Use : Yes

Device Count : 1

3D Dental - Joy - 00817169020196 Catalog Number :

Device Description : JOY ETCH SYRINGE 12ML

Device Class : 2

Duns Number: 080194935

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

3D Dental - Joy - 00817169020202 Catalog Number :

Device Description : JOY ETCH BULK BOX OF 25

Device Class : 2

Duns Number: 080194935

Premarket Exempt : No

Product Code : KLE

Prescription Use : No

Device Count : 1

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