SAFCO DENTAL SUPPLY CO.

Address:1111 CORPORATE GROVE DRIVE,Buffalo Grove,IL,60089,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

DAM, RUBBER (EIE) (4) Polymer patient examination glove (LZA) (4) BUR, DENTAL (EJL) (2)

Premarket Exempt

No Yes

Clear

Safco DENTA-SAFE DENTAL DAM - 10810063750197 Catalog Number : 1020751

Device Description : Medium (0.18mm-0.23mm thickness) 5" x 5", box of 52

Device Class : 1

Duns Number: 020417380

Premarket Exempt : Yes

Product Code : EIE

Prescription Use : No

Device Count : 52

Safco DENTA-SAFE DENTAL DAM - 10810063750203 Catalog Number : 1020755

Device Description : Medium (0.18mm-0.23mm thickness) 6" x 6", box of 36

Device Class : 1

Duns Number: 020417380

Premarket Exempt : Yes

Product Code : EIE

Prescription Use : No

Device Count : 36

Safco DENTA-SAFE DENTAL DAM - 10810063750210 Catalog Number : 1020759

Device Description : Heavy (0.23mm-0.28mm thickness) 5" x 5", box of 52

Device Class : 1

Duns Number: 020417380

Premarket Exempt : Yes

Product Code : EIE

Prescription Use : No

Device Count : 52

Safco DENTA-SAFE DENTAL DAM - 10810063750227 Catalog Number : 1020764

Device Description : Heavy (0.23mm-0.28mm thickness) 6" x 6", box of 36

Device Class : 1

Duns Number: 020417380

Premarket Exempt : Yes

Product Code : EIE

Prescription Use : No

Device Count : 36

Nitrilex Surpass gloves - 10810063750791 Catalog Number : 1027990

Device Description : Safco Nitrilex Surpass X-small 300/box

Device Class : 1

Duns Number: 020417380

Premarket Exempt : Yes

Product Code : LZA

Prescription Use : No

Device Count : 300

Nitrilex Surpass gloves - 10810063750807 Catalog Number : 1027993

Device Description : Safco Nitrilex Surpass Small 300/box

Device Class : 1

Duns Number: 020417380

Premarket Exempt : Yes

Product Code : LZA

Prescription Use : No

Device Count : 300

Nitrilex Surpass gloves - 10810063750821 Catalog Number : 1027996

Device Description : Safco Nitrilex Surpass Medium 300/box

Device Class : 1

Duns Number: 020417380

Premarket Exempt : Yes

Product Code : LZA

Prescription Use : No

Device Count : 300

Nitrilex Surpass gloves - 10810063750838 Catalog Number : 1027999

Device Description : Safco Nitrilex Surpass Large 300/box

Device Class : 1

Duns Number: 020417380

Premarket Exempt : Yes

Product Code : LZA

Prescription Use : No

Device Count : 300

Safco D1amond - 10810063750913 Catalog Number : 1023901

Device Description : Sterile Single Use Burs - ISO Code 368-018C

Device Class : 1

Duns Number: 020417380

Premarket Exempt : Yes

Product Code : EJL

Prescription Use : No

Device Count : 25

Safco D1amond - 10810063750920 Catalog Number : 1023903

Device Description : Sterile Single Use Burs - ISO Code368-023C

Device Class : 1

Duns Number: 020417380

Premarket Exempt : Yes

Product Code : EJL

Prescription Use : No

Device Count : 25

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