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Sign in to claim this brandCANDID CARE CO.
US
Last updated May 27, 2026
What CANDID CARE CO. makes
Candid Care Co. produces silicone-based dental impression materials designed for capturing precise oral scans, including kits for initial and repeat impressions. They also manufacture orthodontic progressive aligners, custom-fitted devices used to gradually reposition teeth.
Their products are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Candid Care Co. manufacture?
Candid Care Co. specializes in two primary types of dental devices: silicone-based impression materials for capturing detailed oral scans, including kits for initial and repeat impressions, and orthodontic progressive aligners. These aligners are custom-fitted devices designed to gradually shift teeth into desired positions over time.
Where is Candid Care Co. based, and what does that mean for their regulatory oversight?
Candid Care Co. is based in the United States, which means their devices are subject to FDA regulations. Since the company’s products fall under FDA’s Class I and Class II categories, they must comply with applicable FDA requirements for safety, performance, and labeling, though Class I devices generally face less stringent oversight than Class II.
Which regulatory registries or databases list Candid Care Co.’s devices?
Candid Care Co.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the medical device supply chain by assigning a unique code to each device, helping track recalls, compliance, and post-market surveillance.
How are Candid Care Co.’s devices classified by the FDA, and what does that classification imply?
Candid Care Co.’s devices are classified under FDA’s Class I and Class II categories. Class I devices, like some impression materials, typically pose minimal risk and require general controls (e.g., labeling, manufacturing practices). Class II devices, such as orthodontic aligners, involve moderate risk and may require special controls (e.g., performance standards or post-market surveillance) to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- candidco.com
- —
- —
- [email protected]
- Phone
- 9177542056
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 108729170
Catalogue (25)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Candid Impression Kit | IKDIGITAL00004 | FDA UDI | Class I | Active |
| Candid Redo Impression Kit | URBD0004 | FDA UDI | Class I | Active |
| Candid Redo Impression Kit | RDKETTS0001 | FDA UDI | Class II | Active |
| Candid Redo Impression Kit | RDLGORANGE00001 | FDA UDI | Class I | Active |
| Candid Impression Kit | IKMESHFINISHED00002 | FDA UDI | Class II | Active |
| Candid Aligner | FA-0003 | FDA UDI | Class II | Active |
| Candid Aligner | FA-0001 | FDA UDI | Class II | Active |
| Candid Redo Impression Kit | URBD0003 | FDA UDI | Class I | Active |
| Candid Redo Impression Kit | UBRD0002 | FDA UDI | Class I | Active |
| Candid Impression Kit | IKDIGITAL00003 | FDA UDI | Class I | Active |
| Candid Impression Kit | IKDIGITAL00002 | FDA UDI | Class II | Active |
| Candid Redo Impression Kit | RDKETTM0001 | FDA UDI | Class II | Active |
| Candid Refinement Impression Kit | ITISK00001 | FDA UDI | Class II | Active |
| Candid Impression Kit | IKFINISHED00002 | FDA UDI | Class I | Active |
| Candid Impression Kit | IKMIXFINISHED00001 | FDA UDI | Class I | Active |
| Candid Impression Kit | FGS-0010 | FDA UDI | Class I | Active |
| Candid Redo Impression Kit | RDKETTL0001 | FDA UDI | Class II | Active |
| Candid Impression Kit | IKMESHFINISHED00001 | FDA UDI | Class II | Active |
| Candid Impression Kit | IKDIGITAL00005 | FDA UDI | Class I | Active |
| Candid Impression Kit | FGS-0009 | FDA UDI | Class II | Active |
| Candid Aligner | FA-0001 | FDA UDI | Class II | Unknown |
| Candid Redo Impression Kit | RDMDPAT00001 | FDA UDI | Class I | Active |
| Candid Redo Impression Kit | RDMDORANGE00001 | FDA UDI | Class I | Active |
| Candid Redo Impression Kit | RDSMORANGE00001 | FDA UDI | Class I | Active |
| Candid Impression Kit | IKHELLO00001 | FDA UDI | Class I | Active |
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