Data / Medical devices / United States / Reko Dental, LLC

Reko Dental, LLC: FDA-registered device maker in Gardena, CA, United States, 5 510(k) clearances

Name: Reko Dental, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Reko Dental, LLC is registered with the FDA (registration 2087259) in Gardena, CA, United States. It lists 19 device types. The FDA files 5 510(k) clearances under its listings, the newest dated August 27, 2013. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2087259
FEI number: 3003381355
Address: 17800 SOUTH MAIN, No. 201, Gardena, CA, United States, 90248
Owner or operator: MANUFACTURERA DENTAL CONTINENTAL (9032760)
Roles: Complaint file establishment, Repackager or relabeler, Specification developer
First device listed: January 20, 1998
Registered through: 2026
Brand names listed: AntiVet Whitening Kit, Bio-Jel, Bisacryl NicTone, Calibrated Wax, Confident Denture Adhesive Cream, Confident Denture Adhesive Powder, Confident Denture Cleaner, EDGE Condensation and more

Devices it lists

Device	Product code	Class	Role	Source
Abutment, Implant, Dental, Endosseous	NHA	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Agent, Polishing, Abrasive, Oral Cavity	EJR	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Alloy, Metal, Base	EJH	2	Complaint file establishment	accessdata.fda.gov
Articulators	EJP	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium	KOT	1	Complaint file establishment	accessdata.fda.gov
Cleanser, Denture, Over The Counter	EFT	1	Complaint file establishment	accessdata.fda.gov
Crown And Bridge, Temporary, Resin	EBG	2	Complaint file establishment	accessdata.fda.gov
Dam, Rubber	EIE	1	Complaint file establishment	accessdata.fda.gov
Eraser, Dental Stain	MAU	1	Complaint file establishment	accessdata.fda.gov
Frame, Rubber Dam	EJE	1	Complaint file establishment	accessdata.fda.gov
Implant, Endosseous, Root-Form	DZE	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Light, Operating, Dental	EAZ	1	Complaint file establishment	accessdata.fda.gov
Material, Impression	ELW	2	Complaint file establishment	accessdata.fda.gov
Reliner, Denture, Over The Counter	EBP	2	Complaint file establishment	accessdata.fda.gov
Resin, Denture, Relining, Repairing, Rebasing	EBI	2	Complaint file establishment	accessdata.fda.gov
Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue	OCL	2	Complaint file establishment	accessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	NOF	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Teeth, Artificial, Backing And Facing	ELK	1	Complaint file establishment	accessdata.fda.gov
Wax, Dental, Intraoral	EGD	1	Complaint file establishment, Repackager or relabeler, Specification developer	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
August 27, 2013	K130462	PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANT	DZE	Substantially Equivalent	Paltop Advanced Dental Solutions, Ltd.	accessdata.fda.gov
August 22, 2013	K131451	PALTOP DENTAL IMPLANT - STERILE ACCESSORIES	DZE	Substantially Equivalent	Paltop Advanced Dental Solutions, Ltd.	accessdata.fda.gov
April 20, 2012	K112795	PALTOP DENTAL IMPLANT SYSTEM	DZE	Substantially Equivalent	Paltop Advanced Dental Solutions, Ltd.	accessdata.fda.gov
September 4, 2001	K011785	NOVEL PRINT CYAN ALGINATES	ELW	Substantially Equivalent	Manufacturera Dental Continental	accessdata.fda.gov
September 22, 1999	K991577	NIC TONE ACRYLIC RESINS	EBI	Substantially Equivalent	Manufacturera Dental Continental	accessdata.fda.gov

Compare with other makers

Updated August 27, 2013. 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.