Manufacturer registered with FDA
Candid Care Co.
Columbus, OH, United States. Lists 6 dental device types with FDA across 2 registered establishments.
- Device types listed
- 6
- Brands and models
- 22
- 510(k) clearances
- 0as applicant
- Markets registered in
- 414 registrations outside the US
- Establishments
- 2Mexico, United States
Registered in 4 markets
Where regulators' registries name Candid Care Co. 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 | Candid Care Co. | 6 device types | — | Below |
| Canada | Health Canada | Registration holder | CANDID CARE CO. | 12 | 2022–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Candid Care Co | 1 | 2024–2024 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Candid Care Co. | 1 | — | 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 Candid Care Co. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| All Types RetractorEIG · Class 1 | Dental hand instruments | Lister | Candid Cheek RetractorScanBox Pro | 2018 |
| Sequential AlignerNXC · Class 2 | Clear aligners | Maker | Candid AlignerCandid Aligner Kit FGS-0001, FGS-0002; Candid Care Replacement Kit FGS-0004; Candid Care Refinement Kit FGS-0008Candid Clear AlignerFGS-2002 Glidewell Aligner KitFGS-2004 Glidewell Replacement KitFGS-2008 Glidewell Refinement KitFGS-3002 Oliv Aligner KitFGS-3004 Oliv Replacement KitFGS-3008 Oliv Refinement KitProMonitoring Aligner Kit | 2020 |
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Maker | Candid Care RetainerCandid Care Retainer Kit FGS-0003FGS-0003 PermaForm RetainerFGS-2003 PermaForm Retainer GlidewellFGS-3003 PermaForm Retainer OlivPermaForm Retainer | 2022 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Lister | Candid Tray | 2018 |
| Impression MaterialELW · Class 2 | Impression materials | Lister | Kettenbach Impression Kt | 2019 |
| Oral Irrigation KitOGT · Class 1 | — | Maker | FGS-0005 Whitening KitZOOM! Whitening Procedure Kit | 2022 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Candid Care Co. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Voodoo Manufacturing, Inc. (1), Kettenbach GmbH & Co. KG (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 9 May 2019 | K190948 | Magic Clear Aligners | Voodoo Manufacturing, Inc. | NXC Sequential Aligner |
| 8 Sep 2008 | K082560 | PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT | Kettenbach GmbH & Co. KG | ELW Impression Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Border Assembly S. de R.L de C.V.FDA reg. 3023401336 | Tijuana Baja California, Mexico | Contract manufacturer, Manufacturer, Repacker / relabeler |
| Candid Care Co.FDA reg. 3015179606 | Columbus, OH, United States | Complaint file establishment, Repacker / relabeler |
Other names on FDA records
Border Assembly S. de R.L de C.V.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10055632). 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.