Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010131268

FEI Number

3010131268

Entity Name

Dharma Research/Medeco International

City/State/Country

Miami, FL, US

Establishment Address

5220 NW 72ND AVE STE 15, Miami, FL 33166, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Dharma Research, Inc. (Owner Number: 10043856)

Owner / Operator Contact Address

5220 N.W. 72nd. Avenue, Unit #15, Miami, FL 33166, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K790788

PMA Number

N/A

All Registered Proprietary Names

Dharma Eugenol ADS Eugenol Dharma Calcium Hydroxide ADS Zinc Oxide Sherbet Zinc Oxide Sherbet Calcium Hydroxide ADS Calcium Hydroxide Dharma Zinc Oxide Sherbet Eugenol Calix-CHG Chlorhexidine Irrigation Solution ADS Sodium Hypochlorite Solution Calix-E EDTA Irrigation Solution Calix Sodium Hypochlorite Solution Calix-X Enhanced Sodium Hypochlorite Solution ADS Chlorhexidine Irrigation Solution ADS EDTA Irrigation Solution Sherbet Chlorhexidine Irrigation Solution ADS Enhanced Sodium Hypochlorite Solution Sherbet EDTA Irrigation Solution Sherbet Enhanced Sodium Hypochlorite Solution Sherbet Sodium Hypochlorite Solution ADS Prophylaxis Paste Gelo-X Gel (Paste) Qartz Prophylaxis Paste Sherbet Prophylaxis Paste ADS Etchant Gels Jade Etchant Gels Sherbet Etchant Gels ADS Fluoride Varnish Citrine Fluoride Varnish Sherbet Fluoride Varnish Enthus Impression Material ADS Impression Material Sherbet Impression Material Ionite Fluoride Trays ADS Fluoride Trays Sherbet Fluoride Trays ADS Pit & Fissure Sealant Opaque Khameo Pit & Fissure Sealant Opaque Khameo Pit & Fissure Sealant Clear Sherbet Pit & Fissure Sealant Opaque ADS Pit & Fissure Sealant Clear Sherbet Pit & Fissure Sealant Clear

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EMB	Zinc Oxide Eugenol	Dental	Class 1	872.3275	2014-06-18
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	2014-06-18
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2013-03-28
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2016-09-07
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2014-08-27
ELW	Material, Impression	Dental	Class 2	872.3660	2014-06-18
KMT	Tray, Fluoride, Disposable	Dental	Class 1	872.6870	2013-03-28
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2014-08-27

Official Correspondent

Ricardo Carles

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Dharma Research, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K121698	Dentsply International, Inc.	NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN	2012-08-06
K020499	Jeneric/Pentron, Inc.	BOND-3 ADHESIVE	2002-04-22
K801093	Dentsply Intl.	PRISMA-BOND	1980-05-20
K061981	Apex Dental Materials, Inc.	SURPASS	2006-07-31
K110302	3M Espe AG	ADHESIVE EXL-759	2011-05-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.

Similar Registrations

Registration Number	Establishment Name	Location
3011545201	KI. WORKS VIETNAM CO., LTD	Mongkok, Kln., Hong Kong, HK
2515379	DENTSPLY LLC	MILFORD, DE, US
1719513	MEDTECH PRODUCTS, INC.	Tarrytown, NY, US
3040335058	INDIVATION EXPORTS PRIVATE LIMITED	Gurugram Haryana, IN
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010131268. Last updated year: 2026. Please use registration number 3010131268 when referencing this establishment in official correspondence.