FDA Registration
Active
🇲🇽 Mexico
MANUFACTURERA DENTAL CONTINENTAL
Reg #: 9616065
·
FEI: 1000531402
·
Expires 2026
Products
17
Proprietary Names
31
Establishment Types
4
Classifications
17
Registration Details
- Registration Name
- MANUFACTURERA DENTAL CONTINENTAL
- Registration Number
- 9616065
- FEI Number
- 1000531402
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2113 CALLE INDUST DEL PLASTICO, 269 FRACC ZAPOPAN INDUST NORTE
- City
- ZAPOPAN Jalisco
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K991577
Owner / Operator
- Firm Name
- MANUFACTURERA DENTAL CONTINENTAL
- Operator Number
- 9032760
- Address
- 2113 CALLE INDUST DEL PLASTICO, 269 FRACC ZAPOPAN INDUST NORTE
- City
- ZAPOPAN, JALISCO
- State
- MX-NOTA
- Postal Code
- 45210
- Country
- MX
US Agent
- Business Name
- GSM Services
- Contact Name
- Gary Mocnik
- Address
- 49 Coastal Oak
- City
- Aliso Viejo
- State
- CA
- ZIP
- 92656
- Country
- US
- [email protected]
- Phone
- 949 4330413
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2007-12-03 |
| Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue | OCL | Class 2 | General, Plastic Surgery | No | 2007-12-03 |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2007-12-03 |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | Class 1 | Dental | No | 2020-07-23 |
| Frame, Rubber Dam | EJE | Class 1 | Dental | No | 1998-01-20 |
| Cleanser, Denture, Over The Counter | EFT | Class 1 | Dental | No | 2018-11-01 |
| Material, Impression | ELW | Class 2 | Dental | No | 2007-12-03 |
| Articulators | EJP | Class 1 | Dental | No | 2017-06-20 |
| Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium | KOT | Class 1 | Dental | No | 2015-03-10 |
| Eraser, Dental Stain | MAU | Class 1 | Dental | No | 2014-08-26 |
| Dam, Rubber | EIE | Class 1 | Dental | No | 1998-01-20 |
| Light, Operating, Dental | EAZ | Class 1 | Dental | No | 2001-05-15 |
| Teeth, Artificial, Backing And Facing | ELK | Class 1 | Dental | No | 2002-01-14 |
| Reliner, Denture, Over The Counter | EBP | Class 2 | Dental | No | 2022-09-05 |
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2017-09-21 |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | Class 2 | Dental | No | 2018-12-07 |
| Alloy, Metal, Base | EJH | Class 2 | Dental | No | 2019-12-16 |
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
Calibrated Wax
Rogson Wax
i500: MD-ID300 Dental Scanner
Medit i700 Dental Scanner
Medit i700 Wireless Dental Scanner
Mesa Alloys
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Export Device to the United States But Perform No Other Operation on Device