Manufacturer registered with FDA
Laboratorios Dentales de Zona Franca, S.A.
CARTAGO, Costa Rica. Lists 6 dental device types with FDA across 1 registered establishment.
- Device types listed
- 6
- Brands and models
- 23
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1Costa Rica
Devices listed with FDA
What Laboratorios Dentales de Zona Franca, S.A. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Custom Abutment - 3i CertainCustom Abutment - AnkylosCustom Abutment - AstraCustom Abutment - Astra EVCustom Abutment - BiohorizonsCustom Abutment - BranemarkCustom Abutment - CamlogCustom Abutment - HiossenCustom Abutment - MegagenCustom Abutment - Nobel Active 6 moreCustom Abutment - Nobel ReplaceCustom Abutment - Straumann BLXCustom Abutment - Straumann Bone LevelCustom Abutment - Straumann SynOctaCustom Abutment - Zimmer TSVGold Custom Abutment | 2024 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | Comfort 3D Bite SplintThermoforming Nightguard/Mouthguard/Bleaching Tray | 2022 |
| Anti-Snoring DeviceLRK · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | Elastic Mandibular Advancement (EMA) applianceSilent Nite sl | 2024 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Custom Abutment - Hahn | 2024 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Duplication stent | 2025 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Surgical Guide | 2024 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Laboratorios Dentales de Zona Franca, S.A. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Prismatik Dentalcraft, Inc. (13).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 12 Jul 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 | Prismatik Dentalcraft, Inc. | NHA Endosseous Dental Implant Abutment |
| 26 Sep 2023 | K223496 | Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Systems | Prismatik Dentalcraft, Inc. | NHA Endosseous Dental Implant Abutment |
| 5 Aug 2019 | K191222 | Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV | Prismatik Dentalcraft, Inc. | NHA Endosseous Dental Implant Abutment |
| 6 Jun 2017 | K170044 | Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System | Prismatik Dentalcraft, Inc. | NHA Endosseous Dental Implant Abutment |
| 16 Nov 2015 | K151798 | Inclusive Titanium Abutments compatible with: Straumann synOcta Implant System | Prismatik Dentalcraft, Inc. | NHA Endosseous Dental Implant Abutment |
| 7 Oct 2015 | K151375 | Inclusive Titanium Abutments compatible with: Hiossen HG Implant System | Prismatik Dentalcraft, Inc. | NHA Endosseous Dental Implant Abutment |
| 1 Oct 2015 | K143515 | Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and Nobel Biocare NobelReplace Implants | Prismatik Dentalcraft, Inc. | NHA Endosseous Dental Implant Abutment |
| 2 Apr 2015 | K143353 | Hahn Tapered Implant System | Prismatik Dentalcraft, Inc. | DZE Root-Form Endosseous Implant |
| 6 Jan 2015 | K141923 | INCLUSIVE TITANIUM ABUTMENTS, COMPATIBLE WITH DENTSPLY IMPLANTS ANKYLOS C/X | Prismatik Dentalcraft, Inc. | NHA Endosseous Dental Implant Abutment |
| 25 Nov 2014 | K142118 | INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: STRAUMANN BONE LEVEL, NOBEL BIOCARE BRANAE | Prismatik Dentalcraft, Inc. | NHA Endosseous Dental Implant Abutment |
| 13 Nov 2014 | K142115 | INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: ZIMMER, BIOMET 3I, AND NOBEL BIOCARE IMPLANT | Prismatik Dentalcraft, Inc. | NHA Endosseous Dental Implant Abutment |
| 10 Dec 2012 | K121391 | INCLUSIVE TITANIUM ABUTMENTS FOR CAMLOG SCREW-LINE IMPLANTS | Prismatik Dentalcraft, Inc. | NHA Endosseous Dental Implant Abutment |
| 28 Dec 2010 | K100993 | INCLUSIVE TITANIUM ABUTMENTS FOR ASTRA TECH OSSEOSPEED IMPLANTS | Prismatik Dentalcraft, Inc. | NHA Endosseous Dental Implant Abutment |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| LABORATORIOS DENTALES DE ZONA FRANCA, S.A.FDA reg. 3001295407 | CARTAGO, Costa Rica | Contract manufacturer, Manufacturer |
Other names on FDA records
Laboratorios Dentales de Zona Franca, S.A.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9012389). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.