Dharma Research/Medeco International

Miami, FL, US

Dharma Research/Medeco International appears in FDA device records in Miami, FL. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 2 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 1
PMA records: 0
Recall records: 2
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Dharma Research/Medeco International carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Dharma Research, Inc.510(k), enforcement report, recall

510(k) clearance history

FDA records hold 1 510(k) clearance for Dharma Research/Medeco International in 2015.

Clearances by year, as a table

510(k) clearance decisions for Dharma Research/Medeco International, by decision year
Year	Clearances
2015	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K150696	Jade 37% Phosphoric Acid Etchant Gel	KLE	Substantially Equivalent	2015-06-23

Registered establishments

FDA registered establishments for Dharma Research/Medeco International, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3010131268	3010131268	Dharma Research/Medeco International	5220 NW 72ND AVE STE 15, Miami, FL 33166 US	2026	EBC EBF EFH EIC EIE EJR ELW EMB KLE KMT and 1 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-0476-2015	Dharma Cavity Varnish 15mL	During an FDA inspection it was found that the products are marketed without a cleared 510k.	Class II	2014-09-29	Terminated
Z-0475-2015	Dharma Cavity Varnish with Fluoride	During an FDA inspection, it was found that the products are being marketed without a cleared 510k.	Class II	2014-09-29	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain