Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014749460

FEI Number

3014749460

Entity Name

Envista (Suzhou) Medical Device Co., Ltd.

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

1st floor 2nd floor Building 18#, No.8 Jinfeng Road, Suzhou Jiangsu 215163, CN

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

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
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2018-11-01
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2025-07-02
ECQ	Aligner, Bracket, Orthodontic	Dental	Class 1	872.4565	1982-12-15
PNN	Orthodontic Software	Dental	Class 2	872.5470	2021-04-20
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2021-04-20
DYT	Maintainer, Space Preformed, Orthodontic	Dental	Class 1	872.5525	2023-11-17

Official Correspondent

No official correspondent registered.

US Agent Details

Procoro Herrera Business: SYBRON DENTAL SPECIALTIES, INC. Email: SybronDentalSpecialtiesRA@Envistaco.com Phone: (657) 3416074

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
3028340833	EH Labs CZ s.r.o.	Dvur Kralove nad Labem Hradec Kralove, CZ

Similar Registrations

Registration Number	Establishment Name	Location
3027500898	EH Dental Services Costa Rica Sociedad de Responsabilidad Limitada	Escazu, San Rafael San Jose, CR
3035691085	CRISTALINE ALIGNERS GMBH	Pforzheim Baden-Wurttemberg, DE
3031606517	Envista (Sichuan) Medical Device Co., Ltd.	Ziyang Sichuan, CN
3009011037	MEM DENTAL TECHNOLOGY CO LTD	Tainan, TW
3017155477	uLab Systems, Inc	Memphis, TN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014749460. Last updated year: 2026. Please use registration number 3014749460 when referencing this establishment in official correspondence.