Manufacturer registered with FDA
Dharma Research, Inc.
Miami, FL, United States. Lists 11 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 11
- Brands and models
- 52
- 510(k) clearances
- 12015–2015
- Markets registered in
- 630 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 6 markets
Where regulators' registries name Dharma Research, Inc. 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 | Dharma Research, Inc. | 1 clearances | 2015–2015 | Below |
| Colombia | INVIMA | Registration holder | DHARMA RESEARCH, INCDHARMA RESEARCH INC | 19 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Dharma Research, Inc.Dharma Research Inc. | 5 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Dharma Research, Inc. | 3 | 2014–2014 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | DHARMA RESEARCH, INC. | 2 | 2015–2018 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | DHARMA RESEARCH, INC. | 1 | 2020–2020 | 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 Dharma Research, 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 |
|---|---|---|---|---|
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Lister | ADS Pit & Fissure Sealant ClearADS Pit & Fissure Sealant OpaqueKhameo Pit & Fissure Sealant ClearKhameo Pit & Fissure Sealant OpaqueSherbet Pit & Fissure Sealant ClearSherbet Pit & Fissure Sealant Opaque | 2014 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Lister | ADS Hema DesensitizerLapiss Hema DesensitizerSherbet Hema Desensitizer | 2014 |
| Articulation PaperEFH · Class 1 | — | Lister | ADS Articulating PaperEhros Articulating PaperSherbet Articulating Paper | 2014 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Maker | ADS Chlorhexidine Irrigation SolutionADS EDTA Irrigation SolutionADS Enhanced Sodium Hypochlorite SolutionADS Sodium Hypochlorite SolutionCalix Sodium Hypochlorite SolutionCalix-CHG Chlorhexidine Irrigation SolutionCalix-E EDTA Irrigation SolutionCalix-X Enhanced Sodium Hypochlorite SolutionSherbet Chlorhexidine Irrigation SolutionSherbet EDTA Irrigation Solution 2 moreSherbet Enhanced Sodium Hypochlorite SolutionSherbet Sodium Hypochlorite Solution | 2014 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Lister | ADS Dental DamEhros Dental DamSherbet Dental Dam | 2014 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | ADS Prophylaxis PasteGelo-X Gel (Paste)Qartz Prophylaxis PasteSherbet Prophylaxis Paste | 2013 |
| Impression MaterialELW · Class 2 | Impression materials | Lister | ADS Impression MaterialEnthus Impression MaterialSherbet Impression Material | 2014 |
| Zinc Oxide EugenolEMB · Class 1 | Dental cements | Lister | ADS Calcium HydroxideADS EugenolADS Zinc OxideDharma Calcium HydroxideDharma EugenolDharma Zinc OxideSherbet Calcium HydroxideSherbet EugenolSherbet Zinc Oxide | 2014 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | ADS Etchant GelsJade Etchant GelsSherbet Etchant Gels | 2016 |
| Disposable Fluoride TrayKMT · Class 1 | — | Lister | ADS Fluoride TraysIonite Fluoride TraysSherbet Fluoride Trays | 2013 |
| Cavity VarnishLBH · Class 2 | Sealants & varnishes | Lister | ADS Fluoride VarnishCitrine Fluoride VarnishSherbet Fluoride Varnish | 2014 |
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 Dharma Research, Inc. as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 23 Jun 2015 | K150696 | Jade 37% Phosphoric Acid Etchant Gel | KLE Resin Tooth Bonding Agent |
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
Dharma Research, 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: Scientific Pharmaceuticals (3), Crown Delta Corp. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 14 May 2004 | K041028 | CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL | Crown Delta Corp. | ELW Impression Material |
| 17 Dec 1998 | K983305 | SCI-PHARM DESENSITIZING VARNISH | Scientific Pharmaceuticals | LBH Cavity Varnish |
| 21 Jul 1987 | K872569 | TEMREX ETCHING GEL | Scientific Pharmaceuticals | EBF Resin Tooth Shade Material |
| 6 Jul 1979 | K790788 | FISSURE SEALER AND BONDING AGENT | Scientific Pharmaceuticals | EBC Pit and Fissure Sealant and Conditioner |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Dharma Research/Medeco InternationalFDA reg. 3010131268 | Miami, FL, United States | Contract manufacturer, Manufacturer, Repacker / relabeler |
Other names on FDA records
Dharma Research/Medeco International
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10043856). 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.