Smarthealth, Inc.

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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) (8) CROWN AND BRIDGE, TEMPORARY, RESIN (EBG) (2)

Premarket Exempt

No Yes

Clear

SmartPractice - D766SP6931251 Catalog Number : SP693125

Device Description : S/P IMPRESSION MATL VPS HVY BODY REG 50ML*4 658-00475 #VP8007

Device Class :

Duns Number: 061081477

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 4

SmartPractice - D766SP6931261 Catalog Number : SP693126

Device Description : S/P IMPRESSION MATL VPS LT BODY F/S 50ML CART*4 #VP8003S

Device Class :

Duns Number: 061081477

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 4

SmartPractice - D766SP6931271 Catalog Number : SP693127

Device Description : S/P IMPRESSION MATL VPS LT BODY R/S 50ML CART*4 658-00472

Device Class :

Duns Number: 061081477

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 4

SmartPractice - D766SP6931281 Catalog Number : SP693128

Device Description : S/P IMPRESSION MATL VPS MED BODY 50ML*4 658-00474

Device Class :

Duns Number: 061081477

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 4

SmartPractice - D766SP6931291 Catalog Number : SP693129

Device Description : S/P IMPRESSION MATL VPS MONOPHASE 50ML *4 658-00476

Device Class :

Duns Number: 061081477

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 4

SmartPractice - D766SP6931301 Catalog Number : SP693130

Device Description : S/P HIGH PERF VPS PUTTY R/S 300ML BASE/CAT #658-00477

Device Class : 2

Duns Number: 061081477

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 1

SmartPractice - D766SP6931321 Catalog Number : SP693132

Device Description : S/P IMPRESSION MATL VPS MED BODY FS 50ML*4 #VP9009

Device Class :

Duns Number: 061081477

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 4

SmartPractice - D766SP6931331 Catalog Number : SP693133

Device Description : S/P IMPRESSION MATL VPS MONOPHASE FS 50ML*4 #VP9005

Device Class :

Duns Number: 061081477

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 4

SmartPractice - D766SP6941371 Catalog Number : SP694137

Device Description : S/P TEMP C&B DBL A1 +TIPS 658-00482

Device Class : 2

Duns Number: 061081477

Premarket Exempt : No

Product Code : EBG

Prescription Use : No

Device Count : 1

SmartPractice - D766SP6941381 Catalog Number : SP694138

Device Description : S/P TEMP C&B DBL A2 +TIPS 658-00483

Device Class : 2

Duns Number: 061081477

Premarket Exempt : No

Product Code : EBG

Prescription Use : No

Device Count : 1

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