Espe GmbH (US)

Mchenry, IL, US

Espe GmbH (Us) appears in FDA device records in Mchenry, IL. FDA records list 59 510(k) clearances between 1977-06-01 and 1993-06-18, no PMA records and no registered establishments. As of 2026-09-10, FDA records show no recalls for this company.

510(k) clearances: 59
PMA records: 0
Recall records: 0
Registered establishments: 0

510(k) clearance history

Showing 50 of 59

FDA records hold 59 510(k) clearances for Espe GmbH (US) between 1977 and 1993. The busiest year on record is 1977, with 13. The most recent is 1993, with 1.

Clearances by year, as a table

510(k) clearance decisions for Espe GmbH (US), by decision year
Year	Clearances
1977	13
1979	3
1981	1
1982	2
1984	2
1985	2
1986	3
1987	2
1988	10
1989	7
1990	8
1991	3
1992	2
1993	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K925027	PHOTAC-FIL APLICAP	EMA	Substantially Equivalent	1993-06-18
K915005	PHOTAC-BOND APLICAP, MODIFICATION	EMA	Substantially Equivalent	1992-01-14
K913966	SONO(R) -CEM	EBF	Substantially Equivalent	1992-01-14
K913857	ROCATEC(R) -PLUS	EJH	Substantially Equivalent	1991-12-16
K913965	ESPE(R) -SIL	KLE	Substantially Equivalent	1991-12-04
K905604	VISIO-GEM ART-SYSTEM	EBF	Substantially Equivalent	1991-03-29
K904096	PHOTAC-BOND	EJK	Substantially Equivalent	1990-11-19
K904097	PHOTAC-BOND APLICAP	EJK	Substantially Equivalent	1990-11-09
K904289	PERTAC UNIVERSAL BOND	KLE	Substantially Equivalent	1990-11-01
K900510	PERTAC-HYBRID	EBF	Substantially Equivalent	1990-08-09
K900558	PERTAC BOND	KLE	Substantially Equivalent	1990-04-10
K900436	PROTEMP II	EBG	Substantially Equivalent	1990-03-28
K897188	KETAC-CEM MAXICAP	EMA	Substantially Equivalent	1990-03-27
K896539	PERMADYNE GARANT LOW VISCOSITY	ELW	Substantially Equivalent	1990-02-09
K892412	POLYETHER-RETARDER	ELW	Substantially Equivalent	1989-12-04
K892839	PALGARAPID	ELW	Substantially Equivalent	1989-10-27
K892517	TULUX-FILTER	EBZ	Substantially Equivalent	1989-08-21
K891064	ESPE CAPMIX	EFD	Substantially Equivalent	1989-05-30
K891020	ESPE TULUX-CEM	EBF	Substantially Equivalent	1989-05-26
K884752	KETAC-GLAZE	KLE	Substantially Equivalent	1989-01-19
K884381	PALGAFLEX AND PALGAFLEX-QUICK	ELW	Substantially Equivalent	1989-01-04
K884475	CHELON-FIL	EMA	Substantially Equivalent	1988-12-05
K882566	VISIO-PERL	EBF	Substantially Equivalent	1988-10-19
K881838	MODIFIED PERMAGUM ADHESIVE	EBH	Substantially Equivalent	1988-07-27
K880741	ESPE VARNISH	LBH	Substantially Equivalent	1988-07-01
K874788	KETAC-BOND APLICAP	EMA	Substantially Equivalent	1988-04-12
K875257	IMPREGUM F ADHESIVE	EBH	Substantially Equivalent	1988-03-09
K875228	PERMADYNE ADHESIVE	EBH	Substantially Equivalent	1988-03-09
K872984	KETAC-CONDITIONER	EMA	Substantially Equivalent	1988-03-09
K875133	CAVIT-W	EBG	Substantially Equivalent	1988-03-01
K873882	ALKALINER	EJK	Substantially Equivalent	1988-02-26
K873069	MODIFIED VISIO-SEAL	EBC	Substantially Equivalent	1987-09-15
K865028	ESPE CHELON-SILVER	EBF	Substantially Equivalent	1987-02-19
K862292	ESPE VISIO-MOLAR	EBF	Substantially Equivalent	1986-08-18
K853529	IMPREGUM-F	ELW	Substantially Equivalent	1986-03-17
K844844	ESPE NIMETIC-GRIP	DYH	Substantially Equivalent	1986-02-13
K844845	ESPE KETAC-BOND	EBD	Substantially Equivalent	1985-08-19
K844846	ESPE KETAC-CEM RADIOPAQUE	EMA	Substantially Equivalent	1985-03-25
K843566	KETAC-SILVER	EMA	Substantially Equivalent	1984-12-06
K833757	VISIO-GEM	EBF	Substantially Equivalent	1984-02-03
K822452	PROTEMP	EBG	Substantially Equivalent	1982-09-28
K822453	VISIO-OPAQUER	EBF	Substantially Equivalent	1982-09-14
K812169	VISIO-FIL	EBF	Substantially Equivalent	1981-09-08
K790823	VISIO-DISPERS	EBF	Substantially Equivalent	1979-10-22
K790833	VISIO-BOND	KLE	Unknown	1979-04-30
K790832	KETAC APPLIC-CAPSULES	EMA	Unknown	1979-04-30
K771852	NIMETIC POLISHING PASTE	EJR	Substantially Equivalent	1977-11-02
K771853	PERMAGUM ADHESIVE	ELW	Substantially Equivalent	1977-10-13
K771654	NIMETICAP	EBF	Substantially Equivalent	1977-09-06
K771627	PERMAGUM	ELW	Substantially Equivalent	1977-09-02

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

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