SUNSTAR AMERICAS, INC.

Address:301 East Central Road,Schaumburg,IL,60195,US

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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

Bone Grafting Material, Synthetic (LYC) (1) Varnish, Cavity (LBH) (1)

Premarket Exempt

No Yes

Clear

GUIDOR - 07640164360140 Catalog Number : C11-007

Device Description : Bone grafting material, synthetic

Device Class : 2

Duns Number: 025066358

Premarket Exempt : No

Product Code : LYC

Prescription Use : Yes

Device Count : 1

BUTLER MONSTERZ - 10070942002025 Catalog Number :

Device Description : A liquid substance used in dentistry consisting of one or more resins in an orga A liquid substance used in dentistry consisting of one or more resins in an organic solvent, used for the protection of pulpal tissue and to provide a marginal seal to newly placed amalgam restorations. After application, this device cannot be reused.White liquid Fluoride Varnish, 5% w/w Sodium Fluoride

Device Class : 2

Duns Number: 025066358

Premarket Exempt : No

Product Code : LBH

Prescription Use : Yes

Device Count : 1

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