Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1054415

FEI Number

3003069616

Entity Name

CDB CORPORATION

City/State/Country

Leland, NC, US

Establishment Address

8770 Trade Street, Suite A, Leland, NC 28451, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CDB CORP. (Owner Number: 9002860)

Owner / Operator Contact Address

8770 Trade St, Suite A, Leland, NC 28451, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K973776

PMA Number

N/A

All Registered Proprietary Names

CDB Clip RELECTIONS HDH Treatment Planning System HIT Clear Aligners Buttons

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NJM	Bracket, Ceramic, Orthodontic	Dental	Class 2	872.5470	2019-12-02
DYW	Bracket, Plastic, Orthodontic	Dental	Class 2	872.5470	2016-04-13
NJM	Bracket, Ceramic, Orthodontic	Dental	Class 2	872.5470	2009-10-26
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	1992-06-19
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2024-12-06
PNN	Orthodontic Software	Dental	Class 2	872.5470	2024-12-06
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2014-05-08
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2019-12-27
DYW	Bracket, Plastic, Orthodontic	Dental	Class 2	872.5470	2005-08-12

Official Correspondent

Alex Lorenzo

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CDB CORP.

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
K180404	3M Healthcare	3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System	2018-03-16
K894358	Ormco Corp.	LUMINA ORTHODONTIC BRACKET	1989-09-15
K925012	American Orthodontics	PLASTIC CHAIN	1993-09-13
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007	AGFA Corp.	2	IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

Similar Registrations

Registration Number	Establishment Name	Location
3009011037	MEM DENTAL TECHNOLOGY CO LTD	Tainan, TW
2024980	YOUNG INNOVATIONS INC.	Algonquin, IL, US
3027460334	LightForce Orthodontics	Wilmington, MA, US
3016543896	CSY INTERNATIONAL LLC	Rancho Cucamonga, CA, US
1000118628	FIVE STAR ORTHODONTIC LABORATORY & SUPPLY, INC.	Denton, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1054415. Last updated year: 2026. Please use registration number 1054415 when referencing this establishment in official correspondence.