Keystone Industries

Address:52 West King St,Myerstown,PA,17067,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 - H66810005031 Catalog Number : 1000503

Device Description : HC 5 llb Pwd Clear

Device Class : 2

Duns Number: 073503117

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Sledgehammer - H66810005041 Catalog Number : 1000504

Device Description : HC 25 lb Pwd Clear

Device Class : 2

Duns Number: 073503117

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Sledgehammer - H66810005071 Catalog Number : 1000507

Device Description : SC 1 lb Pwd Light Red Pink

Device Class : 2

Duns Number: 073503117

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Sledgehammer - H66810005081 Catalog Number : 1000508

Device Description : SC 5 llb Pwd Light Red Pink

Device Class : 2

Duns Number: 073503117

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Sledgehammer - H66810005091 Catalog Number : 1000509

Device Description : SC 25 lb Pwd Light Red Pink

Device Class : 2

Duns Number: 073503117

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Sledgehammer - H66810005101 Catalog Number : 1000510

Device Description : SC 1 lb Pwd Original

Device Class : 2

Duns Number: 073503117

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Sledgehammer - H66810005111 Catalog Number : 1000511

Device Description : SC 5 llb Pwd Original

Device Class : 2

Duns Number: 073503117

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Sledgehammer - H66810005121 Catalog Number : 1000512

Device Description : SC 25 lb Pwd Original

Device Class : 2

Duns Number: 073503117

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Sledgehammer - H66810005131 Catalog Number : 1000513

Device Description : SC 1 lb Pwd Clear

Device Class : 2

Duns Number: 073503117

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Sledgehammer - H66810005141 Catalog Number : 1000514

Device Description : SC 5 llb Pwd Clear

Device Class : 2

Duns Number: 073503117

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

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