Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3001295407

FEI Number

3001295407

Entity Name

LABORATORIOS DENTALES DE ZONA FRANCA, S.A.

City/State/Country

CARTAGO, CR

Establishment Address

ENTRADA A HIGUITO, SAN ISIDRO DEL GUARCO, CARTAGO 30802, CR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LABORATORIOS DENTALES DE ZONA FRANCA, S.A (Owner Number: 9012389)

Owner / Operator Contact Address

ENTRADA A HIGUITO, SAN ISIDRO DEL GUARCO, CARTAGO, CR-C 30802, CR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K142118

PMA Number

N/A

All Registered Proprietary Names

Orthodontic Prosthesis Full Dentures Custom Abutment - Astra EV Custom Abutment - Straumann BLX Custom Abutment - Hahn Gold Custom Abutment Acrylic/flexible partials Duplication stent Custom Abutment - Ankylos Comfort 3D Bite Splint Custom Abutment - Nobel Replace Custom Abutment - 3i Certain Custom Abutment - Zimmer TSV Premise Indicrect Inlays/Onlays/Crown/Post/Wing/Veneer Elastic Mandibular Advancement (EMA) appliance Yellow Gold Metal Crown Foundation Bridge Semi-Precious Post in Crown Full Cast 50 Crown OcclusalGold Metal Crown Foundation Full Cast Yellow Noble Inlay/Onlay Crown White High Noble Post in Crown Semi-Precious Metal Crown Foundation White Gold Metal Crown Foundation Yellow High Noble Crown Foundation White High Noble Crown Foundation Jrvt Gold Crown Semi-Precious Crown Foundation Noble Restoration Crown/Substructure/Inlay/Onlay Yellow Noble Crown Foundation Semi-Precious Metal Crown Foundation Bridge Jrvt Gold Inlay/Onlay Crown Full Cast White High Noble Crown Full Yellow High Noble Gold Crown Captek Crown Foundation Captek Crown Foundation Bridge Yellow High Noble Post in Crown Yellow Gold Metal Crown Foundation Full Cast Semi-Precious Inlay/Onlay Crown Full Cast Semi-Precious Crown White Gold Metal Crown Foundation Bridge Full Cast Galileo Crown Telescopic Coping - Metal Coping Captek Coping OcclusalGold Metal Crown Foundation Bridge Full Cast Yellow Gold Crown Full Cast Yellow High Noble Gold Inlay/Onlay Crown Noble Metal Restoration Silent Nite sl Custom Abutment - Hiossen Custom Abutment - Megagen Porcelain Fused to Gold Crown Foundation Bridge Sculpture Fused to Non - Precious Crown Porcelain to Semi-Precious Metal Crown Bridge Porcelain to Semi-Precious Metal Occlusal Crown Bridge Porcelain to Non-Precious Metal Unfinished Crown Sculpture Fused to Semi - Precious Crown Porcelain Fused to White High Noble Crown Bridge Porcelain Fused to Gold Crown Bridge Open Face Gold Crown PF to White High Noble Metal Occlusal Crown Bridge Porcelain to Non-Precious Metal Occlusal Crown Porcelain Fused to Gold with Metal Occlusal Crown Bridge Porcelain to Semi-Precious Metal Crown Porcelain Fused to Gold with Metal Occlusal Crown Porcelain to Semi-Precious Metal Unfinished Crown Captek Unfinished Crown Captek Crown Bridge Porcelain Fused to White High Noble Metal Occlusal Crown Porcelain Fused to White High Noble Crown Captek Crown Porcelain to Semi-Precious Metal Occlusal Unfinished Crown Porcelain Fused to Gold Crown Porcelain to Non-Precious Metal Crown Bridge PF to White High Noble Metal Occlusal Unfinished Crown Sculpture Fused to White High Noble Crown Porcelain to Non-Precious Metal Crown Porcelain to Non-Precious Metal Occlusal Unfinished Crown Porcelain Fused to Gold Crown Foundation Porcelain Fused to Gold with Metal Occlusal Unfinished Crown Porcelain Fused to Gold Unfinished Crown Porcelain to Semi-Precious Metal Occlusal Crown Porcelain Fused to White High Noble Unfinished Crown Porcelain to Non-Precious Metal Occlusal Crown Bridge Sculpture Fused to Yellow High Noble Crown Porcelain Fused to Base metal or Noble Restoration Crown/Bri Porcelain-Fused-To-Metal Restoration Obsidian Porcelain Fused to White High Noble - Crown/Bridge, Inlay/Onlay Obsidian Porcelain Fused to Non-Precious Metal - Crown/Bridge, Inlay/Onlay Obsidian Porcelain Fused to Semi-Precious Metal - Crown/Bridge, Inlay/Onlay Custom Abutment - Branemark Custom Abutment - Nobel Active Custom Abutment - Straumann Bone Level

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NSR	Prosthesis, Orthodontic	Unknown	Class N	N/A	2024-12-05
NSL	Dentures, Full	Unknown	Class N	N/A	2011-04-26
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-12-09
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-02-03
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2024-12-09
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-12-20
NSK	Dentures, Partial	Unknown	Class N	N/A	2011-04-26
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2025-12-15
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-12-09
KMY	Positioner, Tooth, Preformed	Dental	Class 1	872.5525	2024-03-01
MQC	Mouthguard, Prescription	Unknown	Class U	N/A	2024-03-01
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-12-09
NSN	Restoration, Resin, Crown And Bridge	Unknown	Class N	N/A	2012-04-27
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2024-01-15
NSJ	Restoration, Noble Metal	Unknown	Class N	N/A	2011-02-21
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2024-01-15
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-12-09
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-12-09
NSO	Restoration, Porcelain-Fused-To-Metal	Unknown	Class N	N/A	2011-02-22
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-12-09

Official Correspondent

Michelle Gallup

US Agent Details

Michelle Gallup Email: shelly.gallup@glidewelldental.com Phone: (949) 2223590

Related Public Records

Same Entity

LABORATORIOS DENTALES DE ZONA FRANCA, S.A

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K211871	Faico Medical, LLC	FAICO Dental Implant System and CAD/CAM Abutments	2021-11-18
K081806	Idi Biomedical, LLC	IDI IMPLANT SYSTEM	2008-11-07
K120793	Z-Systems AG	Z-LOOK3 EVO SLM	2012-12-21
K130140	Intra-Lock International	INTRA-LOCK OP DENTAL IMPLANT	2013-08-01
K925778	Nobelpharma USA, Inc.	BRANEMARK SYSTEM LAB. AND EDUCATIONAL ACCESSORIES	1993-04-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2018	Implant Direct Sybron Manufacturing, LLC	2	Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
Z-0010-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Z-0017-2026	S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil	2	IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N; IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N; IMPLANT EPIKUT PLUS MT16 4,0X10,0MM, REF: ILM 4010N; IMPLANT EPIKUT PLUS MT16 4,0X11,5MM, REF: ILM 4011N; IMPLANT EPIKUT PLUS MT16 4,0X13,0MM, REF: ILM 4013N; IMP EPIKUT PLUS LONG MT16 4,0X20,0MM, RES: ILM 4020N; IMPLANT EPIKUT PLUS MT16 4,0X8,5MM, RES: ILM 4085N; IMPLANT EPIKUT PLUS MT16 4,5X13,0MM, REF: ILM 4513N; IMPLANT EPIKUT PLUS MT16 4,5X15,0MM, REF: ILM 4515N; IMPLANT EPIKUT PLUS MT16 4,5X8,5MM, REF: ILM 4585N; IMPLANT EPIKUT PLUS MT16 5,0X10,0MM, REF: ILM 5010N; IMPLANT EPIKUT PLUS MT16 5,0X11,5MM, REF: ILM 5011N; IMPLANT EPIKUT PLUS MT16 4,5X10,0MM, REF: ILM 4510N; IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N; IMPLANT EPIKUT PLUS MT16 5,0X15,0MM, REF: ILM 5015N; IMPLANT EPIKUT PLUS MT16 5,0X8,5MM, REF: ILM 5085N; IMP EPIKUT PLUS LONG MT16 4,0X18,0MM, REF: ILM 4018N; IMP EPIKUT PLUS LONG MT16 3,8X18,0MM, REF: ILM 3818N; IMPLANT EPIKUT PLUS MT16 4,5X11,5MM, REF: ILM 4511N; IMPLANT EPIKUT MT16 4,5X15,0MM, REF: ILM 4515; IMPLANT EPIKUT MT16 4,5X8,5MM, REF: ILM 4585; IMPLANT EPIKUT MT16 3,8X13,0MM, REF: ILM 3813; IMPLANT EPIKUT MT16 3,8X15,0MM, REF: ILM 3815; IMPLANT EPIKUT MT16 5,0X8,5MM, REF: ILM 5085; IMPLANT EPIKUT MT16 3,8X11,5MM, REF: ILM 3811; IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N; IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N; IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N
Z-0018-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Z-0019-2020	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	2	Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001295407. Last updated year: 2026. Please use registration number 3001295407 when referencing this establishment in official correspondence.