Manufacturer registered with FDA
Cdb Corporation
Leland, NC, United States. Lists 5 dental device types with FDA across 1 registered establishment, and holds 9 510(k) clearances as applicant.
- Device types listed
- 5
- Brands and models
- 7
- 510(k) clearances
- 91992–2022
- Markets registered in
- 22 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 1990–2026
Registered in 2 markets
Where regulators' registries name Cdb Corporation as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Cdb Corporation | 9 clearances | 1992–2022 | Below |
| Colombia | INVIMA | Manufacturer | CDB CORPORATION | 2 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Cdb Corporation currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic Ceramic BracketNJM · Class 2 | Orthodontic brackets | Maker | CDB ClipCDB Flip-Slide-Clip Bracket | 2009 |
| Orthodontic Plastic BracketDYW · Class 2 | Orthodontic brackets | Maker | Buttons | 2005 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | RELECTIONS | 1992 |
| Sequential AlignerNXC · Class 2 | Clear aligners | Maker | HIT Clear AlignerHIT Clear Aligners | 2019 |
| Orthodontic SoftwarePNN · Class 2 | Dental design & orthodontic software | Maker | HDH Treatment Planning System | 2024 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Cdb Corporation as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 25 Jan 2022 | K212173 | HDH Treatment Planning System | PNN Orthodontic Software |
| 4 Jun 2021 | K210613 | HIT Clear Aligner | NXC Sequential Aligner |
| 20 Dec 2019 | K191823 | Clear-Aligners | NXC Sequential Aligner |
| 27 Sep 2016 | K160957 | CDB Self Ligating Bracket 8F | NJM Orthodontic Ceramic Bracket |
| 7 Aug 2009 | K091702 | CDB FLIP-SIDE-CLIP BRACKET | NJM Orthodontic Ceramic Bracket |
| 17 Oct 2008 | K080906 | CDB CLIP | NJM Orthodontic Ceramic Bracket |
| 21 Nov 1997 | K973776 | REFLECTIONS | DYW Orthodontic Plastic Bracket |
| 1 Feb 1994 | K934881 | REFLECTIONS | EJF Orthodontic Metal Bracket |
| 30 Jul 1992 | K922499 | REFLECTIONS - CERAMIC DENTAL BRACKET | EJF Orthodontic Metal Bracket |
Some of these clearances are listed with FDA today by another company: Ortho Organizers, Inc. (3), Modern Orthodontics (2), Aditek do Brasil SA (1), Leone S.P.A. (1), Sawbros Industries Pvt., Ltd. (1), MPL Manufacturing Inc. (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| CDB CORPORATIONFDA reg. 1054415 | Leland, NC, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9002860). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.