Data / Medical devices / Mexico / Manufacturera Dental Continental

Manufacturera Dental Continental: FDA-registered device maker in ZAPOPAN Jalisco, Mexico, 2 510(k) clearances

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

Manufacturera Dental Continental is registered with the FDA (registration 9616065) in ZAPOPAN Jalisco, Mexico. It lists 17 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 4, 2001. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9616065
FEI number: 1000531402
Address: 2113 Calle Indust Del Plastico 269 Fracc Zapopan Indust Norte, ZAPOPAN Jalisco, Mexico, CP 45210
Owner or operator: MANUFACTURERA DENTAL CONTINENTAL (9032760)
Roles: Complaint file establishment, Exporter to the US, Manufacturer, 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
Agent, Polishing, Abrasive, Oral Cavity	EJR	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Alloy, Metal, Base	EJH	2	Exporter to the US, Specification developer	accessdata.fda.gov
Articulators	EJP	1	Manufacturer	accessdata.fda.gov
Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium	KOT	1	Manufacturer	accessdata.fda.gov
Cleanser, Denture, Over The Counter	EFT	1	Specification developer	accessdata.fda.gov
Crown And Bridge, Temporary, Resin	EBG	2	Manufacturer	accessdata.fda.gov
Dam, Rubber	EIE	1	Manufacturer	accessdata.fda.gov
Eraser, Dental Stain	MAU	1	Manufacturer	accessdata.fda.gov
Frame, Rubber Dam	EJE	1	Manufacturer	accessdata.fda.gov
Light, Operating, Dental	EAZ	1	Manufacturer	accessdata.fda.gov
Material, Impression	ELW	2	Manufacturer	accessdata.fda.gov
Reliner, Denture, Over The Counter	EBP	2	Manufacturer	accessdata.fda.gov
Resin, Denture, Relining, Repairing, Rebasing	EBI	2	Manufacturer	accessdata.fda.gov
Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue	OCL	2	Manufacturer	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	Manufacturer	accessdata.fda.gov
Wax, Dental, Intraoral	EGD	1	Complaint file establishment, Manufacturer	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
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 September 4, 2001. 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.