Registered with FDA
Dent Zar, Inc.
Canoga Park, CA, United States. Lists 9 dental device types with FDA across 1 registered establishment, and holds 12 510(k) clearances as applicant.
- Device types listed
- 9
- Brands and models
- 12
- 510(k) clearances
- 121989–1996
- Markets registered in
- 1United States
- Establishments
- 1United States
510(k) clearances per year, 1980–2026
Devices listed with FDA
What Dent Zar, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Lister | ACORN ANTERIOR/POSTERIOR COMPOSITE RESTORATIVEChemical Cured Bonding AgentENAMEL CONDITIONER (ENAMEL ETCHING AGENT)FANTASTIC CONTACT CURE ORTHODONTIC ADHESIVE FOR PLASTIC AND METAL BRACKETSLIGHT SUPER BOND LIGHT CURED ORTHODONTIC ADHESIVE FOR METAL, PLASTIC AND CERAMIC BRACKETSOrion-1 VL Crown Base and Post Cement Visible Light CureOrion-I Core Build-up Material Chemical Cure | 2007 |
| Dental CementEMA · Class 2 | Dental cements | Lister | — | 2010 |
| Resin Bracket and Tooth Conditioner AdhesiveDYH · Class 2 | — | Lister | Skyrock | 2010 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Lister | SELF CURE BONDING AGENT | 2007 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Lister | DENTAL DIAMOND INSTRUMENTS | 2004 |
| Dental Fiber Optic LightEAY · Class 1 | Dental operating lights | Lister | DENTAL CURING LIGHT | 2004 |
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Lister | — | 2010 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Lister | — | 2010 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Lister | Polishers | 1997 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Dent Zar, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 3 Jul 1996 | K962277 | SELF CURE BONDING AGENT | KLE Resin Tooth Bonding Agent |
| 26 Apr 1996 | K960729 | ENAMEL CONDITIONER (ENAMEL ETCHING AGENT) | EBF Resin Tooth Shade Material |
| 26 Apr 1996 | K960600 | LEXUR ENAMEL COATING-PORCELAIN REPAIR-BONDING VENEERS | EBF Resin Tooth Shade Material |
| 26 Apr 1996 | K960599 | SUPERIOR PHOTOCURING HYBRID COMPOSITE | EBF Resin Tooth Shade Material |
| 26 Apr 1996 | K960598 | CONCORD MARYLAND BRIDGE CEMENT | EBF Resin Tooth Shade Material |
| 26 Apr 1996 | K960597 | ORION-1 VL CROWN BASE AND POST CEMENT VISIBLE LIGHT CURE | EBF Resin Tooth Shade Material |
| 26 Apr 1996 | K960596 | ORION-I CORE BUILD-UP MATERIAL CHEMICAL CURE | EBF Resin Tooth Shade Material |
| 26 Apr 1996 | K960595 | FANTASTIC 1 CONTACT CURE ORTHODONTIC ADHESIVE FOR PLASTIC AND METAL BRACKETS | EBF Resin Tooth Shade Material |
| 26 Apr 1996 | K960594 | LIGHT SUPER BOND-1 LIGHT CURED ORTHODONTIC ADHESIVE FOR METAL, PLASTIC AND CERAMIC BRACKETS | EBF Resin Tooth Shade Material |
| 22 Mar 1996 | K960565 | ACORN ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE | EBF Resin Tooth Shade Material |
| 20 Oct 1989 | K894639 | SKYROCK AND LIGHT SUPERBOND | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 9 Jun 1989 | K891698 | ZAROLAN, DUALAN, TITAN AND SUPERON | EBF Resin Tooth Shade Material |
Also lists devices cleared under other names
Dent Zar, Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Prime Dental Manufacturing, Inc. (7), S & C Polymer GmbH (4).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 23 Jan 2012 | K112574 | PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT | Prime Dental Manufacturing, Inc. | EMA Dental Cement |
| 7 Nov 2002 | K022675 | PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL | Prime Dental Manufacturing, Inc. | EBF Resin Tooth Shade Material |
| 5 Nov 2001 | K012794 | PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT | Prime Dental Manufacturing, Inc. | EBF Resin Tooth Shade Material |
| 1 Nov 2001 | K012761 | PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT | Prime Dental Manufacturing, Inc. | EBC Pit and Fissure Sealant and Conditioner |
| 24 Oct 2001 | K012673 | PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM | Prime Dental Manufacturing, Inc. | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 11 Jun 2001 | K011431 | RESIN CEM | S & C Polymer GmbH | EMA Dental Cement |
| 14 Feb 2001 | K010012 | LC PROVIFILL | S & C Polymer GmbH | EBG Resin Temporary Crown and Bridge |
| 30 May 2000 | K001108 | PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL | Prime Dental Manufacturing, Inc. | EBF Resin Tooth Shade Material |
| 31 Jan 2000 | K994224 | PRIME-DENT CHEMICAL CURE COMPOSITE RESTORATIVE MATERIAL | Prime Dental Manufacturing, Inc. | EBF Resin Tooth Shade Material |
| 9 Mar 1999 | K990108 | LC FLOWFILL | S & C Polymer GmbH | EBF Resin Tooth Shade Material |
| 5 Jun 1998 | K973201 | PROVI CEMENT | S & C Polymer GmbH | EMA Dental Cement |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DENT ZAR, INC.FDA reg. 2027375 | Canoga Park, CA, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 2027375). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.