Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000272892

FEI Number

1000272892

Entity Name

B.J.M. LABORATORIES LTD

City/State/Country

OR-YEHUDA Central, IL

Establishment Address

12 HASADNA ST., INDUSTRIAL PARK, OR-YEHUDA Central 6022011, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

B.J.M. Laboratories Ltd (Owner Number: 9057695)

Owner / Operator Contact Address

12 Hasadna Street, Industrial Park, Or-Yehuda, IL-M 6022011, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K061998

PMA Number

N/A

All Registered Proprietary Names

UNI-Q-Bond Universal Bonding Agent Bond-PR Universal Adhesive Premier Implant Cement Cem-Implant IDEAL 1 Band Cement Kit IDEAL 1 Bracket Adhesive System IDEAL 1 SE Primer STEP-1 PumEtch Resin Tooth Bonding Agent Obturys BJM Root Canal Sealer Activ GP Premier EndoCem Q-Glass Endo Enamel Loc QUICK SEAL Premier Self-Etching Enamel Sealant Q-SEAL Q-Match Universal Restorative Composite Premier's MultiMatch Universal Chameleon Restorative Composite NEOBOND HIGH-Q-BOND LINGUAL RETAINER HIGH-Q-BOND BRACKET PRIMER Q-ETCH ORTHO HIGH-Q-BOND BRACKET comprising PRIMER, LIGHT CURE ADHESIVE, ETCHANT HIGH-Q-BOND BAND CEMENT NEOBAND NEOBOND COMPULES HIGH-Q-BOND BRACKET LIGHT CURE ADHESIVE IN COMPULES HIGH-Q-BOND BRACKET ADHESIVE NEOBOND JR. KIT NEOBOND comprising GEL ETCH, PRIMER, PASTE SYRINGE Spot-On Etch Q-Etch Premier Etch MultiMatch Flow Chameleon AntiMicrobial Composite CompCore AF, Intro and Refill shades Q-CORE, Q-CORE Syringable IDEAL 1 Kit comprising Bracket Adhesive, Primer, Band Cement; Refills HIGH-Q-BOND PREMIER NEXTEMP TEMPORARY CEMENT Q-TEMP High-Q-Bond TotalCem DentoCem High-Q-Bond SE Biocoat Sealant PRIMA SE Primer BondBoost SE PRIMA Quick Prime

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2026-03-11
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2026-03-11
EMA	Cement, Dental	Dental	Class 2	872.3275	2012-11-14
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2016-09-11
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2022-05-16
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2022-05-16
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2026-03-11
EMA	Cement, Dental	Dental	Class 2	872.3275	2012-11-14
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2012-11-14
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2022-12-11
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2012-11-18
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2015-12-09
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2025-11-23
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2025-11-23
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2025-11-23
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2012-11-14
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2012-11-18
EMA	Cement, Dental	Dental	Class 2	872.3275	2012-11-14
EMA	Cement, Dental	Dental	Class 2	872.3275	2026-03-11
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2016-12-11
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2012-11-14

Official Correspondent

Barry Zalsman

US Agent Details

Jessica Huang Business: Premier Dental Products Company Email: jhuang@premierdentalco.com Phone: (610) 2396015

Related Public Records

Same Entity

B.J.M. Laboratories Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K033295	Novamin Technology, Inc.	BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN	2003-10-28
K020499	Jeneric/Pentron, Inc.	BOND-3 ADHESIVE	2002-04-22
K801093	Dentsply Intl.	PRISMA-BOND	1980-05-20
K061981	Apex Dental Materials, Inc.	SURPASS	2006-07-31
K110302	3M Espe AG	ADHESIVE EXL-759	2011-05-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000272892. Last updated year: 2026. Please use registration number 1000272892 when referencing this establishment in official correspondence.