Manufacturer registered with FDA
Manufacturera Dental Continental
ZAPOPAN, JALISCO, Mexico. Lists 18 dental device types with FDA across 2 registered establishments, and holds 2 510(k) clearances as applicant.
- Device types listed
- 18
- Brands and models
- 41
- 510(k) clearances
- 21999–2001
- Markets registered in
- 22 registrations outside the US
- Establishments
- 2Mexico, United States
510(k) clearances per year, 1990–2026
Registered in 2 markets
Where regulators' registries name Manufacturera Dental Continental as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Manufacturera Dental Continental | 2 clearances | 1999–2001 | Below |
| South Korea | MFDS | Manufacturer | Manufacturera Dental Continental | 2 | 2007–2007 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Manufacturera Dental Continental currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Lister | Paltop Dental Sterile AccessoriesPaltop Dynamic C Dental Implant SystemPaltop Narrow Implant, Paltop PCA Dental Implant system | 2020 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Lister | Paltop Dental Sterile AccessoriesPaltop Dynamic C Dental Implant SystemPaltop Narrow Implant, Paltop PCA Dental Implant system | 2020 |
| Dental Operating LightEAZ · Class 1 | Dental operating lights | Maker | MDC DENTAL OPERATING LIGHT | 2001 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | Bisacryl NicToneNic Tone Acrylic ResinsNic Tone PolyCrilNic Tone Selfcure Liquid | 2007 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | Bisacryl NicToneNic Tone Acrylic ResinsNic Tone PolyCrilNic Tone Selfcure Liquid | 2007 |
| Over the Counter Denture RelinerEBP · Class 2 | — | Maker | Edge Liner | 2022 |
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Maker | Confident Denture Cleaner | 2018 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Calibrated WaxRogson Wax | 2017 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | NIC TONE RUBBER DAMNic Tone Synthetic DamReady Dam | 1998 |
| Rubber Dam FrameEJE · Class 1 | Rubber dam systems | Maker | MDC NIC TONE RUBBER DAM | 1998 |
| Base Metal AlloyEJH · Class 2 | Dental alloys | Maker | Mesa Alloys | 2019 |
| ArticulatorsEJP · Class 1 | Articulators & facebows | Maker | MDC Dental Articulator | 2017 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | Polycril | 2020 |
| Backing and Facing Artificial TeethELK · Class 1 | — | Maker | ISOTEK TEETHNEW TEK TEETH | 2002 |
| Impression MaterialELW · Class 2 | Impression materials | Maker | Bio-JelEDGE CondensationMax PrintMax Print CromaticoMax Print CyanNovel Print Cyan AlginatesPVS Edge | 2007 |
| Carboxymethylcellulose Sodium or Polyvinyl Methylether Maleic Acid Calcium-SodiumKOT · Class 1 | Denture cleansers & adhesives | Maker | Confident Denture Adhesive CreamConfident Denture Adhesive Powder | 2015 |
| Dental Stain EraserMAU · Class 1 | — | Maker | AntiVet Whitening Kit | 2014 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | i500: MD-ID300 Dental ScannerMedit i700 Dental ScannerMedit i700 Wireless Dental Scanner | 2018 |
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 Manufacturera Dental Continental as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 4 Sep 2001 | K011785 | NOVEL PRINT CYAN ALGINATES | ELW Impression Material |
| 22 Sep 1999 | K991577 | NIC TONE ACRYLIC RESINS | EBI Rebasing Repairing Relining Denture Resin |
Some of these clearances are listed with FDA today by another company: 3D Dental Designs and Development LLC (1).
Also lists devices cleared under other names
Manufacturera Dental Continental 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: Paltop Advanced Dental Solutions Inc. (3).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 27 Aug 2013 | K130462 | PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANT | Paltop Advanced Dental Solutions Inc. | DZE Root-Form Endosseous Implant |
| 22 Aug 2013 | K131451 | PALTOP DENTAL IMPLANT - STERILE ACCESSORIES | Paltop Advanced Dental Solutions Inc. | DZE Root-Form Endosseous Implant |
| 20 Apr 2012 | K112795 | PALTOP DENTAL IMPLANT SYSTEM | Paltop Advanced Dental Solutions Inc. | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| MANUFACTURERA DENTAL CONTINENTALFDA reg. 9616065 | ZAPOPAN Jalisco, Mexico | Complaint file establishment, Foreign exporter, Manufacturer, Specification developer |
| REKO DENTAL, LLCFDA reg. 2087259 | GARDENA, CA, United States | Complaint file establishment, Repacker / relabeler, Specification developer |
Other names on FDA records
Reko Dental, LLC
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9032760). 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.