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) (6) AGENT, TOOTH BONDING, RESIN (KLE) (2) Indicator, biological sterilization process (FRC) (1) Sterilization wrap containers, trays, cassettes & other accessories (KCT) (1)

Premarket Exempt

No Yes

Clear

SmartPractice - D766SP4400891 Catalog Number : SP440089

Device Description : S/P STERILIZATION POUCH 2.75X10IN*200 658-03082

Device Class :

Duns Number: 061081477

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 200

SmartPractice - D766SP6200181 Catalog Number : SP620018

Device Description : ETCH GEL 37% S/P ENAMEL ETCH BL 1.2ML SYR*4 #FPPRACTIC001

Device Class :

Duns Number: 061081477

Premarket Exempt : No

Product Code : KLE

Prescription Use : No

Device Count : 4

SmartPractice - D766SP6200191 Catalog Number : SP620019

Device Description : ETCH GEL 37% S/P ENAMEL ETCH BL 1.2ML SYR*12 #FPPRACTIC002

Device Class :

Duns Number: 061081477

Premarket Exempt : No

Product Code : KLE

Prescription Use : No

Device Count : 4

SmartPractice - D766SP625661 Catalog Number : SP62566

Device Description : S/P BIO MONITOR MAIL 1 TEST *52 #SPV520

Device Class :

Duns Number: 061081477

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 52

SmartPractice - D766SP658002341 Catalog Number : SP65800234

Device Description : ALGINATE S/P FS 1LB CAN*1 #658-00234

Device Class : 2

Duns Number: 061081477

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 1

SmartPractice - D766SP658002351 Catalog Number : SP65800235

Device Description : ALGINATE S/P RS 1LB CAN*1 #658-00235

Device Class : 2

Duns Number: 061081477

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 1

SmartPractice - D766SP6908421 Catalog Number : SP690842

Device Description : S/P IMPRESSION MATL VPS HVY BODY F/S 50ML*4 #VP9011

Device Class :

Duns Number: 061081477

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 4

SmartPractice - D766SP6931181 Catalog Number : SP693118

Device Description : BITE REG S/P FS 50ML CART*2 #BR9002

Device Class :

Duns Number: 061081477

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 2

SmartPractice - D766SP6931191 Catalog Number : SP693119

Device Description : BITE REG S/P RS 50ML CART*2 #BR9001

Device Class :

Duns Number: 061081477

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 2

SmartPractice - D766SP6931201 Catalog Number : SP693120

Device Description : BITE REG S/P XFS 50ML CART*2 #BR9003

Device Class :

Duns Number: 061081477

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 2

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