B J M Laboratories L T D

FDA Filings

This page includes the latest FDA filings for B J M Laboratories L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 1000272892
• FEI Number: 1000272892
• Name: B.J.M. LABORATORIES LTD
• Owner & Operator: B.J.M. Laboratories Ltd
• Contact Address: 12 Hassadna Street Industrial Park; Or-Yehuda IL-M HaMerkaz 60200 IL
• Official Correspondent:
  • Barry N Zalsman
  • 972-3-7353000-x
• US Agent:
  • Sandy Alves
  • Premier Dental Products Company
  • 610 2396015
  • 610 2396171
  • salves@premusa.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 12 HASSADNA ST. INDUSTRIAL PARK; OR-YEHUDA HaMerkaz, 6022011 IL
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 07290115052886 B.J.M. LABORATORIES LTD	Auto-Cure Activator	2023-11-30
GUDID 07290115050479 B.J.M. LABORATORIES LTD	Porcelain Etch	2023-11-30
GUDID 07290115050462 B.J.M. LABORATORIES LTD	Porcelain Silane	2023-11-30
GUDID 07290115050448 B.J.M. LABORATORIES LTD	Porcelain Fix	2023-11-30
GUDID 07290115050370 B.J.M. LABORATORIES LTD	High-Q-Bond Adhesive Resin Cement Automix	2023-11-30
GUDID 07290115050158 B.J.M. LABORATORIES LTD	Multi Bond	2023-11-30
GUDID 07290115050141 B.J.M. LABORATORIES LTD	Multi Bond	2023-11-30
PMN K161580 | EBC B.J.M. LABORATORIES LTD	Biocoat Sealant	2016-12-11
PMN K050750 | DYH B.J.M. LABORATORIES LTD	IDEAL 1 SE Primer	2016-09-11
PMN K050750 | DYH B.J.M. LABORATORIES LTD	IDEAL 1 Bracket Adhesive System	2016-09-11
PMN K050750 | DYH B.J.M. LABORATORIES LTD	IDEAL 1 Band Cement Kit	2016-09-11
PMN K150601 | EMA B.J.M. LABORATORIES LTD	Zirconite Adhesive Resin Cement	2015-12-09
PMN K150601 | EMA B.J.M. LABORATORIES LTD	Zeramic Adhesive Resin Cement	2015-12-09
PMN K150601 | EMA B.J.M. LABORATORIES LTD	High-Q-Bond SE Adhesive Resin Cement	2015-12-09
PMN K141839 | KLE B.J.M. LABORATORIES LTD	Spot-On Etch	2015-12-09
PMN K141839 | KLE B.J.M. LABORATORIES LTD	Q-Etch	2015-12-09
PMN K141839 | KLE B.J.M. LABORATORIES LTD	Premier Etch	2015-12-09
PMN K131212 | KLE B.J.M. LABORATORIES LTD	Q-Ceram	2013-09-02
PMN K131212 | KLE B.J.M. LABORATORIES LTD	Premier Ceramic Primer	2013-09-02
PMN K040375 | DYH B.J.M. LABORATORIES LTD	Q-ETCH ORTHO	2012-11-18
PMN K040375 | DYH B.J.M. LABORATORIES LTD	NEOBOND	2012-11-18
PMN K040375 | DYH B.J.M. LABORATORIES LTD	NEOBOND comprising GEL ETCH, PRIMER, PASTE SYRINGE	2012-11-18
PMN K040375 | DYH B.J.M. LABORATORIES LTD	NEOBOND JR. KIT	2012-11-18
PMN K040375 | DYH B.J.M. LABORATORIES LTD	NEOBOND COMPULES	2012-11-18
PMN K040375 | DYH B.J.M. LABORATORIES LTD	NEOBAND	2012-11-18
PMN K040375 | DYH B.J.M. LABORATORIES LTD	HIGH-Q-BOND LINGUAL RETAINER	2012-11-18
PMN K040375 | DYH B.J.M. LABORATORIES LTD	HIGH-Q-BOND BRACKET comprising PRIMER, LIGHT CURE ADHESIVE, ETCHANT	2012-11-18
PMN K040375 | DYH B.J.M. LABORATORIES LTD	HIGH-Q-BOND BRACKET PRIMER	2012-11-18
PMN K040375 | DYH B.J.M. LABORATORIES LTD	HIGH-Q-BOND BRACKET LIGHT CURE ADHESIVE IN COMPULES	2012-11-18
PMN K040375 | DYH B.J.M. LABORATORIES LTD	HIGH-Q-BOND BRACKET ADHESIVE	2012-11-18
PMN K040375 | DYH B.J.M. LABORATORIES LTD	HIGH-Q-BOND BAND CEMENT	2012-11-18
PMN K033703 | DYH B.J.M. LABORATORIES LTD	IDEAL 1 Kit comprising Bracket Adhesive, Primer, Band Cement; Refills	2012-11-18
PMN K033703 | DYH B.J.M. LABORATORIES LTD	HIGH-Q-BOND	2012-11-18
PMN K083695 | MVL B.J.M. LABORATORIES LTD	TRAXODENT	2012-11-14
PMN K061998 | KLE B.J.M. LABORATORIES LTD	PRIMA SE Primer	2012-11-14
PMN K061998 | KLE B.J.M. LABORATORIES LTD	PRIMA Quick Prime	2012-11-14
PMN K061998 | KLE B.J.M. LABORATORIES LTD	BondBoost SE	2012-11-14
PMN K061997 | EBC B.J.M. LABORATORIES LTD	QUICK SEAL	2012-11-14
PMN K061997 | EBC B.J.M. LABORATORIES LTD	Q-SEAL	2012-11-14
PMN K061997 | EBC B.J.M. LABORATORIES LTD	Premier Self-Etching Enamel Sealant	2012-11-14
PMN K061997 | EBC B.J.M. LABORATORIES LTD	Enamel Loc	2012-11-14
PMN K051866 | EMA B.J.M. LABORATORIES LTD	Q-TEMP	2012-11-14
PMN K051866 | EMA B.J.M. LABORATORIES LTD	PREMIER NEXTEMP TEMPORARY CEMENT	2012-11-14
PMN K042215 | EMA B.J.M. LABORATORIES LTD	Q-Glass Endo	2012-11-14
PMN K042215 | EMA B.J.M. LABORATORIES LTD	Premier EndoCem	2012-11-14
PMN K042215 | EMA B.J.M. LABORATORIES LTD	Activ GP	2012-11-14
PMN K033309 | EMA B.J.M. LABORATORIES LTD	Premier Implant Cement	2012-11-14
PMN K033309 | EMA B.J.M. LABORATORIES LTD	Cem-Implant	2012-11-14
PMN K012160 | EBF B.J.M. LABORATORIES LTD	Q-CORE, Q-CORE Syringable	2012-11-14
PMN K012160 | EBF B.J.M. LABORATORIES LTD	CompCore AF, Intro and Refill shades	2012-11-14
PMN K933766 | EBF B.J.M. LABORATORIES LTD	ZIRCONITE	2009-01-15
PMN K933766 | EBF B.J.M. LABORATORIES LTD	Q-CERAM	2009-01-15
PMN K933766 | EBF B.J.M. LABORATORIES LTD	PRIMA 2000, PRIMA Quick, PRIMA SE, PRIMA 1, Auto-Cure Activator, Q-ETCH, Q-ETCH UF	2009-01-15
PMN K933766 | EBF B.J.M. LABORATORIES LTD	PORCELAIN FIX comprising ETCH and SILANE	2009-01-15
PMN K933766 | EBF B.J.M. LABORATORIES LTD	PERFECTA	2009-01-15
PMN K933766 | EBF B.J.M. LABORATORIES LTD	MULTIBOND	2009-01-15
PMN K933766 | EBF B.J.M. LABORATORIES LTD	IntegraCem / Bond System, Base and Catalyst	2009-01-15
PMN K933766 | EBF B.J.M. LABORATORIES LTD	IntegraBond Adhesive System, Bond 4ml and 7 ml, Activator and Etchant	2009-01-15
PMN K933766 | EBF B.J.M. LABORATORIES LTD	HIQ-Q-BOND SE	2009-01-15
PMN K933766 | EBF B.J.M. LABORATORIES LTD	HIGH-Q-BOND	2009-01-15
PMN K933766 | EBF B.J.M. LABORATORIES LTD	Block-Out Resin	2009-01-15

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2019032851414	Haifa,Israel -> New York/Newark Area, Newark, New Jersey	SLACף4 BOXES OF 4 CC SYRING LUER LOCK BLACK W CLEAR SILICONE STOPPER ON 1 SKID HS CODE 901831	4 BOX