Data / Medical devices / United States / Dent Zar, Inc.

Dent Zar, Inc.: FDA-registered device maker in Canoga Park, CA, United States, 19 510(k) clearances

Name: Dent Zar, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Dent Zar, Inc. is registered with the FDA (registration 2027375) in Canoga Park, CA, United States. It lists 9 device types. The FDA files 19 510(k) clearances under its listings, the newest dated January 23, 2012. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2027375
Address: 22156 Sherman Way, Unit B, Canoga Park, CA, United States, 91303
Owner or operator: DENT ZAR, INC. (2027375)
Roles: Repackager or relabeler
First device listed: January 30, 1997
Registered through: 2026
Brand names listed: ACORN ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE, Chemical Cured Bonding Agent, DENTAL CURING LIGHT, DENTAL DIAMOND INSTRUMENTS, ENAMEL CONDITIONER (ENAMEL ETCHING AGENT), FANTASTIC CONTACT CURE ORTHODONTIC ADHESIVE FOR PLASTIC AND METAL BRACKETS, LIGHT SUPER BOND LIGHT CURED ORTHODONTIC ADHESIVE FOR METAL, PLASTIC AND CERAMIC BRACKETS, Orion-1 VL Crown Base and Post Cement Visible Light Cure and more

Devices it lists

Device	Product code	Class	Role	Source
Adhesive, Bracket And Tooth Conditioner, Resin	DYH	2	Repackager or relabeler	accessdata.fda.gov
Agent, Polishing, Abrasive, Oral Cavity	EJR	1	Repackager or relabeler	accessdata.fda.gov
Agent, Tooth Bonding, Resin	KLE	2	Repackager or relabeler	accessdata.fda.gov
Cement, Dental	EMA	2	Repackager or relabeler	accessdata.fda.gov
Crown And Bridge, Temporary, Resin	EBG	2	Repackager or relabeler	accessdata.fda.gov
Instrument, Diamond, Dental	DZP	1	Repackager or relabeler	accessdata.fda.gov
Light, Fiber Optic, Dental	EAY	1	Repackager or relabeler	accessdata.fda.gov
Material, Tooth Shade, Resin	EBF	2	Repackager or relabeler	accessdata.fda.gov
Sealant, Pit And Fissure, And Conditioner	EBC	2	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 23, 2012	K112574	PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT	EMA	Substantially Equivalent	Prime Dental Manufacturing, Inc.	accessdata.fda.gov
November 7, 2002	K022675	PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL	EBF	Substantially Equivalent	Prime Dental Manufacturing, Inc.	accessdata.fda.gov
November 5, 2001	K012794	PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT	EBF	Substantially Equivalent	Prime Dental Manufacturing, Inc.	accessdata.fda.gov
November 1, 2001	K012761	PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT	EBC	Substantially Equivalent	Prime Dental Manufacturing, Inc.	accessdata.fda.gov
October 24, 2001	K012673	PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM	DYH	Substantially Equivalent	Prime Dental Manufacturing, Inc.	accessdata.fda.gov
June 11, 2001	K011431	RESIN CEM	EMA	Substantially Equivalent	S & C Polymer GmbH	accessdata.fda.gov
February 14, 2001	K010012	LC PROVIFILL	EBG	Substantially Equivalent	S & C Polymer GmbH	accessdata.fda.gov
May 30, 2000	K001108	PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL	EBF	Substantially Equivalent	Prime Dental Manufacturing, Inc.	accessdata.fda.gov
January 31, 2000	K994224	PRIME-DENT CHEMICAL CURE COMPOSITE RESTORATIVE MATERIAL	EBF	Substantially Equivalent	Prime Dental Manufacturing, Inc.	accessdata.fda.gov
March 9, 1999	K990108	LC FLOWFILL	EBF	Substantially Equivalent	S & C Polymer GmbH	accessdata.fda.gov
June 5, 1998	K973201	PROVI CEMENT	EMA	Substantially Equivalent	S & C Polymer GmbH	accessdata.fda.gov
July 3, 1996	K962277	SELF CURE BONDING AGENT	KLE	Substantially Equivalent	Dent Zar, Inc.	accessdata.fda.gov
April 26, 1996	K960729	ENAMEL CONDITIONER (ENAMEL ETCHING AGENT)	EBF	Substantially Equivalent	Dent Zar, Inc.	accessdata.fda.gov
April 26, 1996	K960597	ORION-1 VL CROWN BASE AND POST CEMENT VISIBLE LIGHT CURE	EBF	Substantially Equivalent	Dent Zar, Inc.	accessdata.fda.gov
April 26, 1996	K960596	ORION-I CORE BUILD-UP MATERIAL CHEMICAL CURE	EBF	Substantially Equivalent	Dent Zar, Inc.	accessdata.fda.gov
April 26, 1996	K960595	FANTASTIC 1 CONTACT CURE ORTHODONTIC ADHESIVE FOR PLASTIC AND METAL BRACKETS	EBF	Substantially Equivalent	Dent Zar, Inc.	accessdata.fda.gov
April 26, 1996	K960594	LIGHT SUPER BOND-1 LIGHT CURED ORTHODONTIC ADHESIVE FOR METAL, PLASTIC AND CERAMIC BRACKETS	EBF	Substantially Equivalent	Dent Zar, Inc.	accessdata.fda.gov
March 22, 1996	K960565	ACORN ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE	EBF	Substantially Equivalent	Dent Zar, Inc.	accessdata.fda.gov
October 20, 1989	K894639	SKYROCK AND LIGHT SUPERBOND	DYH	Substantially Equivalent	Dent Zar, Inc.	accessdata.fda.gov

Compare with other makers

Updated January 23, 2012. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.