Harry J Bosworth Company

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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

LINER, CAVITY, CALCIUM HYDROXIDE (EJK) (4) CEMENT, DENTAL (EMA) (3) CROWN AND BRIDGE, TEMPORARY, RESIN (EBG) (2) SEALANT, PIT AND FISSURE, AND CONDITIONER (EBC) (1)

Premarket Exempt

No Yes

Clear

Bosworth Gorilla Seal - H66809210511 Catalog Number : 0921051

Device Description : LC Sealant Refill

Device Class :

Duns Number: 014769301

Premarket Exempt : No

Product Code : EBC

Prescription Use : Yes

Device Count : 4

Bosworth - H6680921071 Catalog Number : 092107

Device Description : Zinc Phosphate Dental Cement P&L Standard Kit Lt Yellow

Device Class : 2

Duns Number: 014769301

Premarket Exempt : Yes

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Bosworth Hydrox - H66809210711 Catalog Number : 0921071

Device Description : Cavity Liner Base & Catalyst Dentin Kit

Device Class : 2

Duns Number: 014769301

Premarket Exempt : No

Product Code : EJK

Prescription Use : Yes

Device Count : 1

Bosworth Hydrox - H66809210721 Catalog Number : 0921072

Device Description : Cavity Liner Base & Catalyst Ivory Kit

Device Class : 2

Duns Number: 014769301

Premarket Exempt : No

Product Code : EJK

Prescription Use : Yes

Device Count : 1

Bosworth Hydrox - H66809210731 Catalog Number : 0921073

Device Description : Cavity Liner 6 pk Base & Catalyst Ivory Kit

Device Class : 2

Duns Number: 014769301

Premarket Exempt : No

Product Code : EJK

Prescription Use : Yes

Device Count : 1

Bosworth Hydrox - H66809210741 Catalog Number : 0921074

Device Description : Cavity Liner 6 pk Base & Catalyst Dentin Kit

Device Class : 2

Duns Number: 014769301

Premarket Exempt : No

Product Code : EJK

Prescription Use : Yes

Device Count : 1

Bosworth - H6680921081 Catalog Number : 092108

Device Description : Zinc Phosphate Dental Cement 15 ml Liquid

Device Class : 2

Duns Number: 014769301

Premarket Exempt : Yes

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Bosworth Trim II - H66809210901 Catalog Number : 0921090

Device Description : PEMA Temp C&B Standard Kit, 6-1.5 oz Pwd, 4 oz liquid

Device Class : 2

Duns Number: 014769301

Premarket Exempt : Yes

Product Code : EBG

Prescription Use : Yes

Device Count : 1

Bosworth - H6680921091 Catalog Number : 092109

Device Description : Zinc Phosphate Dental Cement Powder 29g Lt Yellow

Device Class : 2

Duns Number: 014769301

Premarket Exempt : Yes

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Bosworth Trim II - H66809210911 Catalog Number : 0921091

Device Description : 4 oz PEMA Liquid, Reg set

Device Class : 2

Duns Number: 014769301

Premarket Exempt : Yes

Product Code : EBG

Prescription Use : Yes

Device Count : 1

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