Unitek Corp.

Mchenry, IL, US

Unitek Corp. appears in FDA device records in Mchenry, IL. FDA records list 23 510(k) clearances between 1980-02-06 and 1994-11-29, no PMA records and no registered establishments. As of 2026-09-10, FDA records show no recalls for this company.

510(k) clearances: 23
PMA records: 0
Recall records: 0
Registered establishments: 0

510(k) clearance history

FDA records hold 23 510(k) clearances for Unitek Corp. between 1980 and 1994. The busiest year on record is 1983, with 5. The most recent is 1994, with 3.

Clearances by year, as a table

510(k) clearance decisions for Unitek Corp., by decision year
Year	Clearances
1980	2
1981	1
1983	5
1984	1
1985	1
1986	1
1988	2
1989	1
1991	2
1992	3
1993	1
1994	3

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K944286	METAL-LINED TRANSCEND CERAMIC BRACKET	DYW	Substantially Equivalent	1994-11-29
K933501	ALASTIK	EJF	Substantially Equivalent	1994-04-28
K940165	ALASTIK	ECI	Substantially Equivalent	1994-03-07
K923999	ALASTIK NS	ECI	Substantially Equivalent	1993-06-24
K924645	TRANSCEND SERIES 6000 DEBONDING INSTRUMENTS	JEX	Substantially Equivalent	1992-11-25
K924295	DEBRACKETING INSTRUMENT	JEX	Substantially Equivalent	1992-11-23
K923432	GERMAN MINI DYNALOCK	EJF	Substantially Equivalent	1992-10-30
K911271	ADHESIVE PRECOATED BRACKETS	DYH	Substantially Equivalent	1991-05-29
K910288	NONSTAINING ALASTIKS	EJF	Substantially Equivalent	1991-03-29
K890529	ALASTIGARD	EJF	Substantially Equivalent	1989-03-09
K880392	ORTHOLUX VISIBLE LIGHT CURING UNIT	EBZ	Substantially Equivalent	1988-04-07
K880393	TRANSBOND LIGHT CURED ORTHODONTIC ADHESIVE	DYH	Substantially Equivalent	1988-03-31
K861965	UNITEK CERAMIC BRACKET SYSTEM	DYW	Substantially Equivalent	1986-06-09
K851386	UNITEK DISPOSABLE IMPRESSION SYRINGE	EID	Substantially Equivalent	1985-04-29
K843742	UNITEK CONVERTIBLE CAP REMOVER TOOL	JEX	Substantially Equivalent	1984-11-09
K832654	HEATED GUTTA PERCHA DELIVERY SYSTEM	EKM	Substantially Equivalent	1983-09-26
K832253	X-704	EJS	Substantially Equivalent	1983-08-31
K831098	DOMINION	EJT	Substantially Equivalent	1983-06-16
K831097	CONCERTO	EJS	Substantially Equivalent	1983-06-15
K831096	STROMA II	EJS	Substantially Equivalent	1983-06-15
K812239	UNITEK PALATAL BAR	DYT	Substantially Equivalent	1981-09-21
K802515	ROOT CANAL POST	ELR	Substantially Equivalent	1980-11-12
K800210	TONGUE HOLDER/SALIVA EJECTOR	DYN	Substantially Equivalent	1980-02-06

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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What MDM checks, and what it does not

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