Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2027375

FEI Number

2027375

Entity Name

DENT ZAR, INC.

City/State/Country

Canoga Park, CA, US

Establishment Address

22156 Sherman Way, Unit B, Canoga Park, CA 91303, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

DENT ZAR, INC. (Owner Number: 2027375)

Owner / Operator Contact Address

22156 Sherman Way, Unit B, --, Canoga Park, CA 91303, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K960597

PMA Number

N/A

All Registered Proprietary Names

FANTASTIC CONTACT CURE ORTHODONTIC ADHESIVE FOR PLASTIC AND METAL BRACKETS DENTAL DIAMOND INSTRUMENTS SELF CURE BONDING AGENT Polishers Orion-I Core Build-up Material Chemical Cure ENAMEL CONDITIONER (ENAMEL ETCHING AGENT) ACORN ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE DENTAL CURING LIGHT Orion-1 VL Crown Base and Post Cement Visible Light Cure

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EMA	Cement, Dental	Dental	Class 2	872.3275	2013-08-19
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-11-05
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2010-03-22
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2010-03-22
DZP	Instrument, Diamond, Dental	Dental	Class 1	872.4535	2004-04-12
EMA	Cement, Dental	Dental	Class 2	872.3275	2010-03-22
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2007-11-05
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	1997-01-30
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2010-03-22
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-11-05
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-11-05
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2010-03-22
EMA	Cement, Dental	Dental	Class 2	872.3275	2013-08-19
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2011-09-08
EAY	Light, Fiber Optic, Dental	Dental	Class 1	872.4620	2004-04-12
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2013-08-19
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2010-03-22
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-11-02

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DENT ZAR, INC.

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
K972485	Arent, Fox, Kintner, Plotkin & Kahn	CIMPAT N	1997-09-08
K982895	Sterngold/Implamed	STERNOMEGA COMPOMER CEMENT	1998-10-09
K033068	Voco GmbH	IONOFIL COLOR AC	2003-10-31
K062064	Southern Dental Industries, Inc.	RIVA BOND LC	2006-11-09
K940030	Bisco, Inc.	BISCO COMPOSITE	1994-02-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.).
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2027375. Last updated year: 2026. Please use registration number 2027375 when referencing this establishment in official correspondence.