EH Labs CZ s.r.o.

FDA Device Registration & Listing · Dvur Kralove nad Labem Hradec Kralove, CZ · Registration 3028340833

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3028340833
FEI Number
3028340833
Entity Name
EH Labs CZ s.r.o.
City/State/Country
Dvur Kralove nad Labem Hradec Kralove, CZ
Establishment Address
Vorlesska 3281, Dvur Kralove nad Labem Hradec Kralove 544 01, CZ
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
SYBRON DENTAL SPECIALTIES, INC. (Owner Number: 9029565)
Owner / Operator Contact Address
1889 W Mission Blvd, --, Pomona, CA 91766, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Spark Clear Aligner System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DYT Maintainer, Space Preformed, Orthodontic Dental Class 1 872.5525 2023-11-17
NXC Aligner, Sequential Dental Class 2 872.5470 2025-07-02
PNN Orthodontic Software Dental Class 2 872.5470 2021-04-20
NXC Aligner, Sequential Dental Class 2 872.5470 2021-04-20
NXC Aligner, Sequential Dental Class 2 872.5470 2018-11-01

Official Correspondent

No official correspondent registered.

US Agent Details

Procoro Herrera Email: SybronDentalSpecialtiesRA@envistaco.com Phone: (714) 8174396

Related Public Records

Same Entity

SYBRON DENTAL SPECIALTIES, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3027500898 EH Dental Services Costa Rica Sociedad de Responsabilidad Limitada Escazu, San Rafael San Jose, CR
3003848022 Metrex Research LLC Madison, WI, US
1722021 METREX RESEARCH Romulus, MI, US
3031606517 Envista (Sichuan) Medical Device Co., Ltd. Ziyang Sichuan, CN
3014749460 Envista (Suzhou) Medical Device Co., Ltd. Suzhou Jiangsu, CN

Similar Registrations

Registration Number Establishment Name Location
8030452 VERTEX-DENTAL B.V. Soesterberg Utrecht, NL
3015143007 SMYLIO Fremont, CA, US
3007513373 E. TEC SA DE C.V. Tijuana Baja California, MX
3019793783 Aceso Dental Laboratory Company Limited An Phuoc Ward Dong Nai, VN
3008910197 Park Dental Research Corp Ardmore, OK, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3028340833. Last updated year: 2026. Please use registration number 3028340833 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.