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

Film, radiographic (IWZ) (4) Indicator, biological sterilization process (FRC) (2) Mouthpiece, saliva ejector (DYN) (2) POINT, PAPER, ENDODONTIC (EKN) (2)

Premarket Exempt

Yes No

Clear

Safco Tru-Verify™ Monitor - D72310274753 Catalog Number : 102-7475

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

Device Class :

Duns Number: 020417380

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 12

Safco Tru-Verify™ Monitor - D72310274783 Catalog Number : 102-7478

Device Description : In-office biological monitor Refill kit 25/kit

Device Class :

Duns Number: 020417380

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 25

Safco X-Pose intraoral x-ray film - D7231027558 Catalog Number : 1027558

Device Description : Safco X-Pose D58 single film

Device Class :

Duns Number: 020417380

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 150

Safco X-Pose intraoral x-ray film - D7231027563 Catalog Number : 1027563

Device Description : Safco X-Pose F58 single film

Device Class :

Duns Number: 020417380

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 150

Safco X-Pose intraoral x-ray film - D7231027571 Catalog Number : 1027571

Device Description : Safco X-Pose D57 double film 130 per bx

Device Class :

Duns Number: 020417380

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 130

Safco X-Pose intraoral x-ray film - D7231027574 Catalog Number : 1027574

Device Description : Safco X-Pose D54 single film

Device Class :

Duns Number: 020417380

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 10

Safco saliva ejectors - D72310276003 Catalog Number : 1027600

Device Description : Safco saliva ejectors clear body

Device Class : 1

Duns Number: 020417380

Premarket Exempt : Yes

Product Code : DYN

Prescription Use : No

Device Count : 100

Safco saliva ejectors - D72310276563 Catalog Number : 1027656

Device Description : Safco saliva ejectors white body

Device Class : 1

Duns Number: 020417380

Premarket Exempt : Yes

Product Code : DYN

Prescription Use : No

Device Count : 100

Safco absorbent points - D72310277053 Catalog Number : 1027705

Device Description : Safco abs pts #15 .04 tapered 100/pk

Device Class : 1

Duns Number: 020417380

Premarket Exempt : Yes

Product Code : EKN

Prescription Use : No

Device Count : 100

Safco absorbent points - D72310277123 Catalog Number : 1027712

Device Description : Safco abs pts #20 .04 tapered 100/pk

Device Class : 1

Duns Number: 020417380

Premarket Exempt : Yes

Product Code : EKN

Prescription Use : No

Device Count : 100

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