Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616065

FEI Number

1000531402

Entity Name

MANUFACTURERA DENTAL CONTINENTAL

City/State/Country

ZAPOPAN Jalisco, MX

Establishment Address

2113 CALLE INDUST DEL PLASTICO, 269 FRACC ZAPOPAN INDUST NORTE, ZAPOPAN Jalisco CP 45210, MX

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MANUFACTURERA DENTAL CONTINENTAL (Owner Number: 9032760)

Owner / Operator Contact Address

2113 CALLE INDUST DEL PLASTICO, 269 FRACC ZAPOPAN INDUST NORTE, ZAPOPAN, JALISCO, MX-NOTA 45210, MX

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Nic Tone Acrylic Resins Nic Tone PolyCril Nic Tone Selfcure Liquid Bisacryl NicTone Polycril MDC NIC TONE RUBBER DAM Confident Denture Cleaner Novel Print Cyan Alginates EDGE Condensation Max Print Cromatico Max Print PVS Edge Bio-Jel Max Print Cyan MDC Dental Articulator Confident Denture Adhesive Powder Confident Denture Adhesive Cream AntiVet Whitening Kit Nic Tone Synthetic Dam Ready Dam NIC TONE RUBBER DAM MDC DENTAL OPERATING LIGHT ISOTEK TEETH NEW TEK TEETH Edge Liner

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2007-12-03
OCL	Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue	General, Plastic Surgery	Class 2	878.4400	2007-12-03
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2007-12-03
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2020-07-23
EJE	Frame, Rubber Dam	Dental	Class 1	872.6300	1998-01-20
EFT	Cleanser, Denture, Over The Counter	Dental	Class 1	872.3520	2018-11-01
ELW	Material, Impression	Dental	Class 2	872.3660	2007-12-03
EJP	Articulators	Dental	Class 1	872.3150	2017-06-20
KOT	Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium	Dental	Class 1	872.3490	2015-03-10
MAU	Eraser, Dental Stain	Dental	Class 1	872.6855	2014-08-26
EIE	Dam, Rubber	Dental	Class 1	872.6300	1998-01-20
EAZ	Light, Operating, Dental	Dental	Class 1	872.4630	2001-05-15
ELK	Teeth, Artificial, Backing And Facing	Dental	Class 1	872.3910	2002-01-14
EBP	Reliner, Denture, Over The Counter	Dental	Class 2	872.3560	2022-09-05

Official Correspondent

No official correspondent registered.

US Agent Details

Gary Mocnik Business: GSM Services Email: gary@gsmservicesus.com Phone: (949) 4330413

Related Public Records

Same Entity

MANUFACTURERA DENTAL CONTINENTAL

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
2087259	REKO DENTAL, LLC	GARDENA, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K120857	Ncontact Surgical, Inc.	EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX	2012-11-13
K800400	Dentsply Intl.	MAXUM DENTURE RESIN	1980-03-12
K033020	Cmp Industries, LLC	IMPAK ACRYLIC REPAIR RESIN LIQUID	2003-12-19
K121698	Dentsply International, Inc.	NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN	2012-08-06
K902838	Denture Dynamic'S, Inc.	DENTURE DYNAMIC'S DENTURE MAGIC	1990-09-06

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1410097	GC AMERICA INC.	ALSIP, IL, US
3015396763	MGNEWTON LTD.	Gyengsan-si Gyeongbuk, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616065. Last updated year: 2026. Please use registration number 9616065 when referencing this establishment in official correspondence.