Safco Dental Supply LLC

Buffalo Grove, IL, US

SAFCO DENTAL SUPPLY LLC appears in FDA device records in Buffalo Grove, IL. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 1
PMA records: 0
Recall records: 1
Registered establishments: 1

510(k) clearance history

FDA records hold 1 510(k) clearance for Safco Dental Supply LLC in 1987.

Clearances by year, as a table

510(k) clearance decisions for Safco Dental Supply LLC, by decision year
Year	Clearances
1987	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K870797	PROPHY CHAMP CORDLESS ELECTRONIC HANDPIECE	EKX	Substantially Equivalent	1987-05-01

Registered establishments

FDA registered establishments for Safco Dental Supply LLC, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
1416277	1416277	SAFCO DENTAL SUPPLY LLC	1111 Corporate Grove Dr., Buffalo Grove, IL 60089 US	2026	No device listings on this registration

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

EKXHandpiece, Direct Drive, Ac-Powered

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-0944-03	Supergrade Earloop Masks, surgical mask; 50 masks per box; Distributed by Safco Dental Supply Co., Northbrook, IL 60062	The product labeling incorrectly lists the particle filtration efficiency as exceeding 99% at 0.1 micron when it should state 95% filtration.		2003-06-03	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain