SUNSTAR AMERICAS, INC.

SUNSTAR AMERICAS, INC.

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

Barrier, Synthetic, Intraoral (NPK) (6) Bone Grafting Material, Synthetic (LYC) (3) Plaque Disclosing Kit (NYH) (1)

Premarket Exempt

No Yes

Clear

GUIDOR - 00070942000017 Catalog Number : 5020

Device Description : GUIDOR® Bioresorbable Matrix Barrier

Device Class : 2

Duns Number: 025066358

Premarket Exempt : No

Product Code : NPK

Prescription Use : Yes

Device Count : 1

GUIDOR - 00070942000031 Catalog Number : 5000

Device Description : GUIDOR® Bioresorbable Matrix Barrier

Device Class : 2

Duns Number: 025066358

Premarket Exempt : No

Product Code : NPK

Prescription Use : Yes

Device Count : 1

GUIDOR - 00070942000048 Catalog Number : 5081

Device Description : GUIDOR® Bioresorbable Matrix Barrier

Device Class : 2

Duns Number: 025066358

Premarket Exempt : No

Product Code : NPK

Prescription Use : Yes

Device Count : 1

GUIDOR - 00070942000055 Catalog Number : 5060

Device Description : GUIDOR® Bioresorbable Matrix Barrier

Device Class : 2

Duns Number: 025066358

Premarket Exempt : No

Product Code : NPK

Prescription Use : Yes

Device Count : 1

GUIDOR - 00070942000062 Catalog Number : 5050

Device Description : GUIDOR® Bioresorbable Matrix Barrier

Device Class : 2

Duns Number: 025066358

Premarket Exempt : No

Product Code : NPK

Prescription Use : Yes

Device Count : 1

GUIDOR - 00070942000079 Catalog Number : 5090

Device Description : GUIDOR® Bioresorbable Matrix Barrier

Device Class : 2

Duns Number: 025066358

Premarket Exempt : No

Product Code : NPK

Prescription Use : Yes

Device Count : 1

RED-COTE - 00070942751469 Catalog Number :

Device Description : This is a caries detection device. It is a plaque disclosing tablet that helps d This is a caries detection device. It is a plaque disclosing tablet that helps detect dental plaque on teeth. The red color reveals areas overlooked when brushing and flossing

Device Class : 2

Duns Number: 025066358

Premarket Exempt : Yes

Product Code : NYH

Prescription Use : No

Device Count : 1

GUIDOR - 07640164360072 Catalog Number : C11-008

Device Description : Bone grafting material, synthetic

Device Class : 2

Duns Number: 025066358

Premarket Exempt : No

Product Code : LYC

Prescription Use : Yes

Device Count : 1

GUIDOR - 07640164360089 Catalog Number : C11-018

Device Description : Bone grafting material, synthetic

Device Class : 2

Duns Number: 025066358

Premarket Exempt : No

Product Code : LYC

Prescription Use : Yes

Device Count : 1

GUIDOR - 07640164360096 Catalog Number : C11-078

Device Description : Bone grafting material, synthetic

Device Class : 2

Duns Number: 025066358

Premarket Exempt : No

Product Code : LYC

Prescription Use : Yes

Device Count : 1

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