Data / Medical devices / United States / CDB Corporation

CDB Corporation: FDA-registered device maker in Leland, NC, United States, 8 510(k) clearances

Name: CDB Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

CDB Corporation is registered with the FDA (registration 1054415) in Leland, NC, United States. It lists 6 device types. The FDA files 8 510(k) clearances under its listings, the newest dated January 25, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1054415
FEI number: 3003069616
Address: 8770 Trade Street Suite A, Leland, NC, United States, 28451
Owner or operator: CDB CORP. (9002860)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed: June 19, 1992
Registered through: 2026
Brand names listed: Buttons, CDB Clip, CDB Flip-Slide-Clip Bracket, HDH Treatment Planning System, HIT Clear Aligner, HIT Clear Aligners, RELECTIONS

Devices it lists

Device	Product code	Class	Role	Source
Aligner, Sequential	NXC	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Bracket, Ceramic, Orthodontic	NJM	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Bracket, Metal, Orthodontic	EJF	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Bracket, Plastic, Orthodontic	DYW	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Orthodontic Software	PNN	2	Complaint file establishment, Specification developer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Complaint file establishment, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 25, 2022	K212173	HDH Treatment Planning System	PNN	Substantially Equivalent	Cdb Corporation	accessdata.fda.gov
June 4, 2021	K210613	HIT Clear Aligner	NXC	Substantially Equivalent	Cdb Corporation	accessdata.fda.gov
December 20, 2019	K191823	Clear-Aligners	NXC	Substantially Equivalent	Cdb Corporation	accessdata.fda.gov
September 27, 2016	K160957	CDB Self Ligating Bracket 8F	NJM	Substantially Equivalent	Cdb Corporation	accessdata.fda.gov
August 7, 2009	K091702	CDB FLIP-SIDE-CLIP BRACKET	NJM	Substantially Equivalent	Cdb Corporation	accessdata.fda.gov
October 17, 2008	K080906	CDB CLIP	NJM	Substantially Equivalent	Cdb Corporation	accessdata.fda.gov
November 21, 1997	K973776	REFLECTIONS	DYW	Substantially Equivalent	Cdb Corp.	accessdata.fda.gov
July 30, 1992	K922499	REFLECTIONS - CERAMIC DENTAL BRACKET	EJF	Substantially Equivalent	Cdb Corp.	accessdata.fda.gov

Compare with other makers

Updated January 25, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.