Keystone Industries

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) (7) AGENT, TOOTH BONDING, RESIN (KLE) (3)

Premarket Exempt

No Yes

Clear

Seity - H66807003771 Catalog Number : 0700377

Device Description : Etch Gel 37% 50 ml Syringe

Device Class : 2

Duns Number: 073503117

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

M&S - H66807021771 Catalog Number : 0702177

Device Description : Etch Gel 37% 50 ml Syringe

Device Class : 2

Duns Number: 073503117

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

Seity - H66807027771 Catalog Number : 0702777

Device Description : Etch Gel 37% 12 g Syringe

Device Class : 2

Duns Number: 073503117

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

Sledgehammer - H66810004701 Catalog Number : 1000470

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

Device Class : 2

Duns Number: 073503117

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Sledgehammer - H66810004711 Catalog Number : 1000471

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

Device Class : 2

Duns Number: 073503117

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Sledgehammer - H66810004721 Catalog Number : 1000472

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

Device Class : 2

Duns Number: 073503117

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Sledgehammer - H66810004731 Catalog Number : 1000473

Device Description : HC 5 lb Pwd & 1 Qt Liq Kit, Lt reddish pink

Device Class : 2

Duns Number: 073503117

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Sledgehammer - H66810004741 Catalog Number : 1000474

Device Description : HC 5 lb Pwd & 1 Qt Liq Kit, Orig

Device Class : 2

Duns Number: 073503117

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Sledgehammer - H66810004751 Catalog Number : 1000475

Device Description : HC 5 lb Pwd & 1 Qt Liq Kit, Clear

Device Class : 2

Duns Number: 073503117

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Sledgehammer - H66810004761 Catalog Number : 1000476

Device Description : HC 25 lb Pwd & 4 Qt Liq Kit, Lt Reddish Pink

Device Class : 2

Duns Number: 073503117

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

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