Data / Medical devices / United States / Dharma Research/Medeco International
Dharma Research/Medeco International: FDA-registered device maker in Miami, FL, United States, 5 510(k) clearances
Dharma Research/Medeco International is registered with the FDA (registration 3010131268) in Miami, FL, United States. It lists 11 device types. The FDA files 5 510(k) clearances under its listings, the newest dated June 23, 2015. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3010131268
- Address
- 5220 NW 72ND Ave Ste 15, Miami, FL, United States, 33166
- Owner or operator
- Dharma Research, Inc. (10043856)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- March 28, 2013
- Registered through
- 2026
- Brand names listed
- ADS Articulating Paper, ADS Calcium Hydroxide, ADS Chlorhexidine Irrigation Solution, ADS Dental Dam, ADS EDTA Irrigation Solution, ADS Enhanced Sodium Hypochlorite Solution, ADS Etchant Gels, ADS Eugenol and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Agent, Polishing, Abrasive, Oral Cavity | EJR | 1 | Manufacturer | accessdata.fda.gov |
| Agent, Tooth Bonding, Resin | KLE | 2 | Manufacturer | accessdata.fda.gov |
| Dam, Rubber | EIE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Repackager or relabeler | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Repackager or relabeler | accessdata.fda.gov |
| Paper, Articulation | EFH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Sealant, Pit And Fissure, And Conditioner | EBC | 2 | Repackager or relabeler | accessdata.fda.gov |
| Syringe, Periodontic, Endodontic, Irrigating | EIC | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Tray, Fluoride, Disposable | KMT | 1 | Repackager or relabeler | accessdata.fda.gov |
| Varnish, Cavity | LBH | 2 | Repackager or relabeler | accessdata.fda.gov |
| Zinc Oxide Eugenol | EMB | 1 | 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 |
|---|---|---|---|---|---|---|
| June 23, 2015 | K150696 | Jade 37% Phosphoric Acid Etchant Gel | KLE | Substantially Equivalent | Dharma Research, Inc. | accessdata.fda.gov |
| May 14, 2004 | K041028 | CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL | ELW | Substantially Equivalent | Crown Delta Corp. | accessdata.fda.gov |
| December 17, 1998 | K983305 | SCI-PHARM DESENSITIZING VARNISH | LBH | Substantially Equivalent | Scientific Pharmaceuticals, Inc. | accessdata.fda.gov |
| July 21, 1987 | K872569 | TEMREX ETCHING GEL | EBF | Substantially Equivalent | Scientific Pharmaceuticals, Inc. | accessdata.fda.gov |
| July 6, 1979 | K790788 | FISSURE SEALER AND BONDING AGENT | EBC | Substantially Equivalent | Scientific Pharmaceuticals, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 29, 2014 | 69386 | Class II | Terminated | Dharma Cavity Varnish with Fluoride | During an FDA inspection, it was found that the products are being marketed without a cleared 510k. | accessdata.fda.gov |
Compare with other makers
- All makers of Sealant, Pit And Fissure, And Conditioner
- All makers of Zinc Oxide Eugenol
- All makers of Agent, Tooth Bonding, Resin
- All makers of Material, Tooth Shade, Resin
- All makers of Tray, Fluoride, Disposable
- All makers of Syringe, Periodontic, Endodontic, Irrigating
Updated June 23, 2015. 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.