KaVo Diagnodent
by Kavo America
De Novo DEN990002
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA De NovoDENG | NumberDEN990002 | Date22 Feb 2000 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA De Novo Active
Specification
- De Novo Number
- FDA Product Code
- NBL
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.1745
- Advisory Committee
- Dental
- FDA Decision
- DENG De Novo granted
Overview
AI-generated summary, 1 Oct 2026
The KaVo Diagnodent is a laser fluorescence caries detection device designed for identifying early-stage dental caries. It employs fluorescence technology to detect demineralization in tooth enamel, enabling clinicians to identify hidden or subtle lesions that may not be visible through visual or tactile examination alone. This aids in the early intervention of caries progression, facilitating minimally invasive treatment approaches.
The device is supplied as a reusable pen-style instrument and is intended for use in dental settings. It requires no sterilization between patients and is classified as a Class II medical device under FDA regulations, with a 510(k) clearance (K-number: DEN990002). The Diagnodent operates under the regulatory framework outlined in 21 CFR 872.1745, ensuring compliance with dental diagnostic standards. No MRI safety or sterility claims are specified beyond standard dental instrument hygiene protocols.
Other devices from Kavo America
Questions
AI-generated answers, 1 Oct 2026
What is the KaVo Diagnodent used for?
The KaVo Diagnodent is designed to identify early-stage dental caries (cavities) by detecting demineralization in tooth enamel through laser fluorescence technology. Unlike traditional visual or tactile methods, it can reveal subtle or hidden lesions that may not be visible to the naked eye, enabling clinicians to intervene before cavities progress. This supports minimally invasive treatment approaches, preserving more of the natural tooth structure.
How is the KaVo Diagnodent supplied and prepared for use?
The Diagnodent is supplied as a reusable pen-style instrument, eliminating the need for sterilization between patients. It is intended for use in dental settings and adheres to standard dental instrument hygiene protocols. Clinicians do not need to perform additional sterilization steps, as the device is engineered for repeated use in a controlled clinical environment.
Is the KaVo Diagnodent single-use or reusable?
The Diagnodent is explicitly designed as a reusable device. Its pen-style form factor and lack of disposable components make it suitable for ongoing use in dental practices. Reusability aligns with its classification as a Class II medical device under FDA regulations, where such instruments are typically intended for repeated clinical applications with proper maintenance.
Does the KaVo Diagnodent require any special storage conditions?
The Diagnodent does not specify unique storage requirements beyond standard conditions for medical devices. It should be stored in a clean, dry environment, protected from physical damage or contamination. Since it is reusable and not sterile between uses, it should be cleaned and maintained according to the manufacturer’s guidelines to ensure accurate performance and longevity.
What regulatory pathway does the KaVo Diagnodent follow?
The Diagnodent follows the FDA’s 510(k) clearance pathway, with a clearance number of DEN990002. It is classified under 21 CFR 872.1745, which governs laser and fluorescence-based caries detection devices. The device was reviewed by the Dental Devices Panel (DE) and cleared post-NSE (Non-Significant Emission), indicating it does not pose significant risks requiring pre-market approval.