Credent Radiopaque Crown & Bride
by Credent Co. 510(k)
Active
510(k) K842476
Overview
The Credent Radiopaque Crown & Bride is a dental restoration device classified as a dental crown and bridge under the FDA’s Product Code EBI. It is designed to provide durable, radiopaque dental prosthetics for crowns and fixed bridges, ensuring visibility under radiographic imaging for diagnostic and treatment planning purposes. Constructed to match natural tooth anatomy, it is intended for use in restorative dentistry to replace missing or damaged teeth with a stable, long-term solution. The radiopacity aids clinicians in assessing fit, positioning, and integration with adjacent structures during follow-up evaluations.
This device is supplied as a single-use or reusable component, depending on clinical protocol and material composition, though specifications do not explicitly state sterility or reuse instructions. It is regulated under the FDA’s 510(k) clearance (K842476) as substantially equivalent to predicate devices, with clearance granted in 1984 under the Dental Advisory Committee (DE). No additional regulatory markings (e.g., CE, ISO) or MRI safety classifications are provided in the available data. Storage conditions are not detailed, but typical dental restorative materials require protection from moisture and contamination until clinical use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK842476 | Date3 Dec 1984 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- EBI
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3760
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Other devices from Credent Co.
Questions
What is the Credent Radiopaque Crown & Bride used for?
The Credent Radiopaque Crown & Bride is designed for dental restorations, specifically as crowns and fixed bridges. Its primary purpose is to replace missing or damaged teeth with durable, long-term solutions that match natural tooth anatomy. The key feature is its radiopacity, which ensures visibility under radiographic imaging, helping clinicians assess fit, positioning, and integration with adjacent structures during diagnostic and treatment planning phases.
Is the Credent Radiopaque Crown & Bride single-use or reusable?
The Credent Radiopaque Crown & Bride can be used either as a single-use or reusable component, depending on clinical protocol and the material composition. The device’s specifications do not explicitly outline sterility or reuse instructions, so clinicians must follow established dental protocols to determine the appropriate use case for their practice.
How does the radiopacity benefit dental treatments?
The radiopacity of the Credent Radiopaque Crown & Bride ensures that the dental restoration is clearly visible on X-rays and other radiographic imaging. This visibility aids clinicians in evaluating the fit, alignment, and integration of the crown or bridge with surrounding teeth and structures. It simplifies diagnostic follow-ups, treatment planning, and long-term monitoring of the restoration’s stability.
What regulatory approval does the Credent Radiopaque Crown & Bride hold?
The Credent Radiopaque Crown & Bride holds FDA 510(k) clearance under the designation K842476. It was granted as substantially equivalent to predicate devices in 1984 by the Dental Advisory Committee (DE). No additional regulatory markings, such as CE or ISO certifications, are mentioned in the available data.
What storage conditions should be followed for this device?
While specific storage instructions are not detailed in the provided data, dental restorative materials like the Credent Radiopaque Crown & Bride generally require protection from moisture and contamination until clinical use. Clinicians should store the device in a clean, dry environment to maintain its integrity and sterility if applicable.