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

FILE, PULP CANAL, ENDODONTIC (EKS) (5) Indicator, biological sterilization process (FRC) (3) MATERIAL, IMPRESSION (ELW) (2)

Premarket Exempt

Yes No

Clear

Safco Maxim K Files and Hedstrom - D72310272703 Catalog Number : 1027270

Device Description : Safco Maxim Hedstrom #55 25mm 6/box

Device Class : 1

Duns Number: 020417380

Premarket Exempt : Yes

Product Code : EKS

Prescription Use : No

Device Count : 6

Safco Maxim K Files and Hedstrom - D72310272763 Catalog Number : 1027276

Device Description : Safco Maxim Hedstrom #60 25mm 6/box

Device Class : 1

Duns Number: 020417380

Premarket Exempt : Yes

Product Code : EKS

Prescription Use : No

Device Count : 6

Safco Maxim K Files and Hedstrom - D72310272813 Catalog Number : 1027281

Device Description : Safco Maxim Hedstrom #70 25mm 6/box

Device Class : 1

Duns Number: 020417380

Premarket Exempt : Yes

Product Code : EKS

Prescription Use : No

Device Count : 6

Safco Maxim K Files and Hedstrom - D72310272883 Catalog Number : 1027288

Device Description : Safco Maxim Hedstrom #80 25mm 6/box

Device Class : 1

Duns Number: 020417380

Premarket Exempt : Yes

Product Code : EKS

Prescription Use : No

Device Count : 6

Safco Maxim K Files and Hedstrom - D72310272933 Catalog Number : 1027293

Device Description : Safco Maxim Hedstrom #45-80 asst 25m

Device Class : 1

Duns Number: 020417380

Premarket Exempt : Yes

Product Code : EKS

Prescription Use : No

Device Count : 6

Nice Bite™ Bite Registration Material - D72310274503 Catalog Number : 102-7450

Device Description : Safco Berry fast set bite registration material 2/pack

Device Class :

Duns Number: 020417380

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 2

Safco Tru-Verify™ Monitor - D72310274523 Catalog Number : 102-7452

Device Description : Mail-in biological monitor 52 test eco kit

Device Class :

Duns Number: 020417380

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 52

Safco Tru-Verify™ Monitor - D72310274593 Catalog Number : 102-7459

Device Description : Mail-in biological monitor 12 test eco kit

Device Class :

Duns Number: 020417380

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 12

Nice Bite™ Bite Registration Material - D72310274643 Catalog Number : 102-7464

Device Description : Safco Berry superfast bite registration material set 2/pk

Device Class :

Duns Number: 020417380

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 2

Safco Tru-Verify™ Monitor - D72310274663 Catalog Number : 102-7466

Device Description : In-office biological monitor Starter Kit 25/kit

Device Class :

Duns Number: 020417380

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 25

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