Talon and Revere
510(k) K071245
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK071245 | Date2 Aug 2007 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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
Overview
AI-generated summary, 1 Oct 2026
The Talon and Revere are thermoplastic dental appliances designed for custom oral applications. Talon is used for fabricating TMJ/D splint appliances, night guards, sleep apnea anti-snore appliances, athletic mouth guards, fluoride trays, and repositioning stints. Revere serves as a resilient liner or reline material for complete dentures, providing a flexible and durable fit.
These devices are supplied as reusable thermoplastic materials, requiring heating and molding to the patient’s oral anatomy. They are intended for dental office use and are not sterile upon packaging. The devices are regulated under FDA 510(k) clearance (K071245) as substantially equivalent to predicate dental appliances, adhering to dental advisory committee standards. No MRI safety information or specific storage requirements are noted in the specifications.
Questions
AI-generated answers, 1 Oct 2026
What are the Talon and Revere thermoplastic materials used for in dental applications?
Talon is designed for fabricating custom dental appliances such as TMJ/D splints, night guards, sleep apnea anti-snore devices, athletic mouth guards, fluoride trays, and repositioning stints. Revere is specifically formulated as a resilient liner or reline material for complete dentures, providing a flexible and comfortable fit. Both materials are intended for dental office use and require heating and molding to the patient’s oral anatomy.
Are Talon and Revere supplied sterile or reusable?
Neither Talon nor Revere is supplied sterile upon packaging. Both are reusable thermoplastic materials that must be heated and molded to the patient’s oral anatomy in a dental office setting. Sterilization is not applicable as these are not single-use items but rather require custom shaping for each application.
How are Talon and Revere regulated by the FDA?
Talon and Revere are regulated under the FDA’s 510(k) clearance process (K071245) and are classified as substantially equivalent to predicate dental appliances. The decision was made by the Dental (DE) Advisory Committee, adhering to dental advisory committee standards. This clearance confirms their compliance with applicable regulatory requirements for dental devices.
Do Talon and Revere have any specific storage requirements?
The specifications for Talon and Revere do not include any specific storage requirements. However, as reusable thermoplastic materials, they should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to maintain their integrity until use. Proper handling ensures they remain suitable for heating and molding in dental applications.
Are there any safety considerations for Talon and Revere, such as MRI compatibility?
The specifications for Talon and Revere do not mention any MRI safety information. Clinicians should exercise caution when using these materials in patients who may require MRI scans, as thermoplastic dental devices are not inherently MRI-safe. Always verify compatibility with the specific MRI system and consult manufacturer guidelines if needed.