Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023401336

FEI Number

3023401336

Entity Name

Border Assembly S. de R.L de C.V.

City/State/Country

Tijuana Baja California, MX

Establishment Address

Andador Arsenio Otanez 12502 Col. El Realito, Tijuana Baja California 22250, MX

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Candid Care Co. (Owner Number: 10055632)

Owner / Operator Contact Address

1200 Chamber Road, Suite 307, Columbus, OH 43212, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Candid Aligner FGS-3002 Oliv Aligner Kit FGS-3008 Oliv Refinement Kit Candid Aligner Kit FGS-0001, FGS-0002; Candid Care Replacement Kit FGS-0004; Candid Care Refinement Kit FGS-0008 FGS-3004 Oliv Replacement Kit FGS-2002 Glidewell Aligner Kit FGS-2004 Glidewell Replacement Kit FGS-2008 Glidewell Refinement Kit ProMonitoring Aligner Kit Kettenbach Impression Kt ZOOM! Whitening Procedure Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2020-09-03
ELW	Material, Impression	Dental	Class 2	872.3660	2019-10-31
OGT	Oral Irrigation Kit	Dental	Class 1	872.6510	2022-03-17

Official Correspondent

Jim Churchill

US Agent Details

Jon Cook Business: Candid Care Co. Email: jon.cook@candidco.com Phone: (408) 5333081

Related Public Records

Same Entity

Candid Care Co.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3015179606	Candid Care Co.	Columbus, OH, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K952614	Dentsply Intl.	JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL	1996-08-13

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 3023401336. Last updated year: 2026. Please use registration number 3023401336 when referencing this establishment in official correspondence.