Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017619720

FEI Number

3017619720

Entity Name

Orthodental S.A. de C.V.

City/State/Country

Mexicali Baja California, MX

Establishment Address

Calle el Dorado #2 interior C & D, Parque Industrial El Dorado, Mexicali Baja California 21383, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

DENTSPLY SIRONA INC (Owner Number: 2511302)

Owner / Operator Contact Address

221 WEST PHILADELPHIA ST., SUITE 60W, York, PA 17401, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SureSmile Aligner Transfer Tray SureSmile Aligner

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2023-10-27
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2026-04-20
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2021-02-12
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2019-12-16

Official Correspondent

No official correspondent registered.

US Agent Details

Dan Eagar Business: DENTSPLY SIRONA INC Email: dan.eagar@dentsplysirona.com Phone: (704) 4926977

Related Public Records

Same Entity

DENTSPLY SIRONA 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
9612618	DEGUDENT GMBH	Rosbach V.D.H. Hesse, DE
3003756493	DENTSPLY INDUSTRIA E COMERCIO LTDA	PIRASSUNUNGA Sao Paulo, BR
3001226627	RECHERCHES TECHNIQUES DENTAIRES (R.T.D.)	ST. EGREVE Isere, FR
3003136642	OraMetrix GmbH	Berlin Brandenburg, DE
3000303964	DENTSPLY DENTAL (TIANJIN) CO., LTD.	TEDA Tianjin, CN

Similar Registrations

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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 3017619720. Last updated year: 2026. Please use registration number 3017619720 when referencing this establishment in official correspondence.