Data / Medical devices / Costa Rica / Laboratorios Dentales De Zona Franca, S.A.
Laboratorios Dentales De Zona Franca, S.A.: FDA-registered device maker in Cartago, Costa Rica, 15 510(k) clearances
Laboratorios Dentales De Zona Franca, S.A. is registered with the FDA (registration 3001295407) in Cartago, Costa Rica. It lists 15 device types. The FDA files 15 510(k) clearances under its listings, the newest dated July 12, 2024. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3001295407
- Address
- Entrada A Higuito San Isidro Del Guarco, Cartago, Costa Rica, 30802
- Owner or operator
- LABORATORIOS DENTALES DE ZONA FRANCA, S.A (9012389)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 28, 2011
- Registered through
- 2027
- Brand names listed
- Acrylic/flexible partials, Base Metal Restoration Crown/Substructure/Inlay/Onlay, BruxZir Esthetic - Crown/Bridge, Inlay/Onlay, Veneer, BruxZir Full Arch Implant Prosthesis, BruxZir Full Contour Zirconia Crown, BruxZir Full Contour Zirconia Crown Bridge, BruxZir Full Contour Zirconia Crown/Bridge/Inlay/Onlay, BruxZir Full Contour Zirconia Inlay/Onlay Crown and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Dentures, Full | NSL | N | Manufacturer | accessdata.fda.gov |
| Dentures, Partial | NSK | N | Manufacturer | accessdata.fda.gov |
| Device, Anti-Snoring | LRK | 2 | Contract manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Manufacturer | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Manufacturer | accessdata.fda.gov |
| Mouthguard, Prescription | MQC | U | Manufacturer | accessdata.fda.gov |
| Positioner, Tooth, Preformed | KMY | 1 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Orthodontic | NSR | N | Manufacturer | accessdata.fda.gov |
| Restoration, Base Metal | NSQ | N | Manufacturer | accessdata.fda.gov |
| Restoration, Noble Metal | NSJ | N | Manufacturer | accessdata.fda.gov |
| Restoration, Porcelain | NSP | N | Manufacturer | accessdata.fda.gov |
| Restoration, Porcelain-Fused-To-Metal | NSO | N | Manufacturer | accessdata.fda.gov |
| Restoration, Resin, Crown And Bridge | NSN | N | 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 |
|---|---|---|---|---|---|---|
| July 12, 2024 | K240240 | Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant Systems | NHA | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| September 26, 2023 | K223496 | Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Systems | NHA | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| October 28, 2020 | K200125 | Thermoforming Sheet Materials | MQC | Substantially Equivalent | Erkodent Erich Kopp GmbH | accessdata.fda.gov |
| November 15, 2019 | K183598 | KeyPrint KeySplint Soft | MQC | Substantially Equivalent | Keystone Industries | accessdata.fda.gov |
| August 5, 2019 | K191222 | Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV | NHA | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| June 6, 2017 | K170044 | Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System | NHA | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| November 16, 2015 | K151798 | Inclusive Titanium Abutments compatible with: Straumann synOcta Implant System | NHA | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| October 7, 2015 | K151375 | Inclusive Titanium Abutments compatible with: Hiossen HG Implant System | NHA | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| October 1, 2015 | K143515 | Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and Nobel Biocare NobelReplace Implants | NHA | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| April 2, 2015 | K143353 | Hahn Tapered Implant System | DZE | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| January 6, 2015 | K141923 | INCLUSIVE TITANIUM ABUTMENTS, COMPATIBLE WITH DENTSPLY IMPLANTS ANKYLOS C/X | NHA | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| November 25, 2014 | K142118 | INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: STRAUMANN BONE LEVEL, NOBEL BIOCARE BRANAE | NHA | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| November 13, 2014 | K142115 | INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: ZIMMER, BIOMET 3I, AND NOBEL BIOCARE IMPLANT | NHA | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| December 10, 2012 | K121391 | INCLUSIVE TITANIUM ABUTMENTS FOR CAMLOG SCREW-LINE IMPLANTS | NHA | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| December 28, 2010 | K100993 | INCLUSIVE TITANIUM ABUTMENTS FOR ASTRA TECH OSSEOSPEED IMPLANTS | NHA | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Restoration, Resin, Crown And Bridge
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Restoration, Noble Metal
- All makers of Device, Anti-Snoring
- All makers of Restoration, Porcelain
- All makers of Implant, Endosseous, Root-Form
Updated July 12, 2024. 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.