Duallor R
by J. Aderer, Inc. 510(k)
Active
510(k) K821572
Overview
The Duallor R is a dental instrument classified as an alloy, other noble metal device. It is designed for use in dental procedures, providing precision tools for manipulation and shaping of dental materials or structures during restorative or surgical interventions.
Supplied as a reusable device, the Duallor R is intended for use in dental offices and clinics. It is regulated under FDA 510(k) clearance (K821572) and falls under product code EJS, with a classification as a Class II medical device. Sterilization and maintenance protocols must adhere to dental instrument standards to ensure safety and functionality.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK821572 | Date14 Jun 1982 | 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- Withdrawn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
- EJS
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3060
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Other devices from J. Aderer, Inc.
Questions
What is the Duallor R used for in dental procedures?
The Duallor R is a dental instrument made from an alloy of other noble metals, designed specifically for precision tasks during restorative or surgical interventions. It is used to manipulate and shape dental materials or structures, ensuring accuracy in procedures like fillings, crowns, or surgical preparations.
Is the Duallor R a single-use or reusable device?
The Duallor R is a reusable dental instrument. Because it is intended for repeated use in clinical settings, proper sterilization and maintenance protocols must be followed to ensure safety and functionality, adhering to standard dental instrument guidelines.
How is the Duallor R sterilized and maintained?
The Duallor R must be sterilized and maintained according to established dental instrument standards. Since it is a reusable device, it requires thorough cleaning and sterilization between uses to prevent cross-contamination and ensure its longevity and performance in dental procedures.
What regulatory approval does the Duallor R hold?
The Duallor R holds FDA 510(k) clearance under the reference number K821572. This classification confirms it meets regulatory standards for safety and effectiveness as a Class II medical device in the dental specialty category.
Where can the Duallor R be used?
The Duallor R is intended for use in dental offices and clinics. Its design and precision make it suitable for procedures requiring careful manipulation of dental materials or structures, such as restorative work or surgical interventions.