Thermaset
510(k) K946255
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK946255 | Date27 Jan 1995 | 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- Withdrawn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
- DYH
- FDA applicant
- Ormco Corp.
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3750
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
Thermaset is an Adhesive, Bracket, and Tooth Conditioner, Resin, classified under FDA regulation number 872.3750. This dental device is designed to prepare tooth surfaces for bonding orthodontic brackets, ensuring optimal adhesion and stability during orthodontic treatment.
Thermaset is supplied as a single-use resin adhesive system for dental applications. It is intended for use in clinical settings by dental professionals and has received FDA 510(k) clearance under the traditional review pathway. The product is categorized under device class II and is regulated under the Dental medical specialty. No information regarding MRI safety or sterility is specified in the provided data.
Other devices from Ormco Corporation
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the Thermaset adhesive system in orthodontic treatment?
Thermaset is designed specifically to prepare tooth surfaces for bonding orthodontic brackets. It acts as an adhesive, bracket, and tooth conditioner to ensure optimal adhesion and stability of the brackets during orthodontic treatment, helping to maintain treatment efficacy throughout the process.
Is Thermaset intended for single-use or can it be reused?
Thermaset is supplied as a single-use resin adhesive system. This means each application is meant for one patient, ensuring sterility and safety in clinical settings where multiple patients are treated.
What types of sizes or models are available for Thermaset?
The provided data lists multiple registration numbers (e.g., 1815540, 3008882689) associated with Thermaset, which likely correspond to different product variants or packaging sizes. While exact specifications like volume or packaging details aren’t described, these identifiers suggest the product may come in various configurations to accommodate different clinical needs.
How is Thermaset regulated and what does its FDA clearance mean for clinicians?
Thermaset received FDA 510(k) clearance under the traditional review pathway, meaning it was determined to be *substantially equivalent* to a legally marketed device already on the market. This classification places it in device class II, indicating it is subject to special controls to ensure safety and effectiveness. Clinicians can rely on this clearance as evidence that the product meets regulatory standards for dental adhesives, brackets, and tooth conditioners.
Is there any information about how Thermaset should be stored or handled?
The provided data does not specify storage instructions or handling requirements for Thermaset. Clinicians should refer to the manufacturer’s (Ormco Corporation) official labeling or instructions for proper storage conditions, shelf life, and handling protocols to ensure optimal performance and safety.