Keystone Industries

Address:616 Hollywood Ave,CHERRY HILL,NJ,08002,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

RESIN, DENTURE, RELINING, REPAIRING, REBASING (EBI) (10)

Premarket Exempt

No Yes

Clear

Sledgehammer - H66810005151 Catalog Number : 1000515

Device Description : SC 25 lb Pwd Clear

Device Class : 2

Duns Number: 073503117

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Sledgehammer - H66810005161 Catalog Number : 1000516

Device Description : HC 8 oz Liquid

Device Class : 2

Duns Number: 073503117

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Sledgehammer - H66810005171 Catalog Number : 1000517

Device Description : HC Quart Liquid

Device Class : 2

Duns Number: 073503117

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Sledgehammer - H66810005181 Catalog Number : 1000518

Device Description : 1 gal HC Liquid

Device Class : 2

Duns Number: 073503117

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Sledgehammer - H66810005211 Catalog Number : 1000521

Device Description : SC 8 oz Liquid

Device Class : 2

Duns Number: 073503117

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Sledgehammer - H66810005221 Catalog Number : 1000522

Device Description : SC Quart Liquid

Device Class : 2

Duns Number: 073503117

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Sledgehammer - H66810005231 Catalog Number : 1000523

Device Description : 1 gal SC Liquid

Device Class : 2

Duns Number: 073503117

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Sledgehammer - H66810005351 Catalog Number : 1000535

Device Description : HC 1 lb Pwd & 8 oz Liq Kit, Lt Fibered

Device Class : 2

Duns Number: 073503117

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Sledgehammer - H66810005361 Catalog Number : 1000536

Device Description : HC 5 llb Pwd & 1 Qt Liq Kit, Lt Fibered

Device Class : 2

Duns Number: 073503117

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Sledgehammer - H66810005391 Catalog Number : 1000539

Device Description : SC 1 lb Pwd & 8 oz Liq Kit, Lt Fibered

Device Class : 2

Duns Number: 073503117

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

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