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) (6) APPLICATOR, RESIN (KXR) (4)

Premarket Exempt

No Yes

Clear

Safco Micro Applicators - 10810063750036 Catalog Number : 1020629

Device Description : Pearl Green, Regular size Applicator, 2mm, 100/tube

Device Class : 1

Duns Number: 020417380

Premarket Exempt : Yes

Product Code : KXR

Prescription Use : No

Device Count : 100

Safco Micro Applicators - 10810063750043 Catalog Number : 1020630

Device Description : Pearl Green Regular size Applicator, 2mm, POD Refill 100/Refill

Device Class : 1

Duns Number: 020417380

Premarket Exempt : Yes

Product Code : KXR

Prescription Use : No

Device Count : 100

Safco Micro Applicators - 10810063750050 Catalog Number : 1020631

Device Description : Lavender, Regular size Applicator, 2mm 100/tube

Device Class : 1

Duns Number: 020417380

Premarket Exempt : Yes

Product Code : KXR

Prescription Use : No

Device Count : 100

Safco Micro Applicators - 10810063750067 Catalog Number : 1020632

Device Description : Lavender Regular size Applicator, 2mm, POD Refill 100/Refill

Device Class : 1

Duns Number: 020417380

Premarket Exempt : Yes

Product Code : KXR

Prescription Use : No

Device Count : 100

Safco DENTA-SAFE NON-LATEX DENTAL DAM - 10810063750135 Catalog Number : 1020768

Device Description : Medium (0.18mm-0.23mm thickness) 5" x 5", box of 20

Device Class : 1

Duns Number: 020417380

Premarket Exempt : Yes

Product Code : EIE

Prescription Use : No

Device Count : 20

Safco DENTA-SAFE NON-LATEX DENTAL DAM - 10810063750142 Catalog Number : 1020772

Device Description : Medium (0.18mm-0.23mm thickness) 6" x 6", box of 15

Device Class : 1

Duns Number: 020417380

Premarket Exempt : Yes

Product Code : EIE

Prescription Use : No

Device Count : 15

Safco DENTA-SAFE NON-LATEX DENTAL DAM - 10810063750159 Catalog Number : 1020777

Device Description : Heavy (0.23mm-0.28mm thickness) 5" x 5", box of 20

Device Class : 1

Duns Number: 020417380

Premarket Exempt : Yes

Product Code : EIE

Prescription Use : No

Device Count : 20

Safco DENTA-SAFE NON-LATEX DENTAL DAM - 10810063750166 Catalog Number : 1020781

Device Description : Heavy (0.23mm-0.28mm thickness) 6" x 6", box of 15

Device Class : 1

Duns Number: 020417380

Premarket Exempt : Yes

Product Code : EIE

Prescription Use : No

Device Count : 15

Safco DENTA-SAFE DENTAL DAM - 10810063750173 Catalog Number : 1020741

Device Description : Light (0.15mm-0.18mm 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 - 10810063750180 Catalog Number : 1020745

Device Description : Light (0.15mm-0.18mm 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

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