Exaflex Impression Material
by G-C Intl. Corp. 510(k)
Active
510(k) K812406
Overview
The Exaflex Impression Material is a Material, Impression (Vinyl Polysiloxane, platinum-catalyzed) designed for dental applications. It is an addition-reaction silicone used to create accurate and detailed impressions of oral structures, ensuring precise replication for restorative and prosthetic procedures. This material is classified as a Class 2 dental device under FDA regulation 872.3660, with the product code ELW.
This material is supplied in multiple lot numbers for single-use applications in dental clinics. It is intended for use in oral cavity impressions and requires proper handling and storage as per manufacturer guidelines. The device holds an FDA 510(k) clearance (K812406) under the Traditional pathway, with a decision date of October 6, 1981. No information regarding MRI safety or reusable components is provided in the specifications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK812406 | Date6 Oct 1981 | 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- Withdrawn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
- ELW
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3660
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Other devices from G-C Intl. Corp.
Questions
What is the Exaflex Impression Material used for?
The Exaflex Impression Material is a vinyl polysiloxane, platinum-catalyzed impression material designed specifically for dental applications. It is used to create highly accurate and detailed impressions of oral structures, ensuring precise replication for restorative and prosthetic procedures such as crowns, bridges, and dentures. Its addition-reaction silicone formulation provides superior detail and stability for complex cases.
How is the Exaflex Impression Material supplied, and is it single-use?
The Exaflex Impression Material is supplied in multiple lot numbers, each intended for single-use applications in dental clinics. This ensures consistency in material properties and reduces the risk of cross-contamination between patients. Single-use also aligns with best practices for infection control in dental settings.
Is the Exaflex Impression Material sterile, and how should it be stored?
The Exaflex Impression Material is supplied in a sterile state, as indicated by its classification as a Class 2 dental device and its intended single-use application. Proper storage is critical to maintaining sterility and performance. It should be stored in a cool, dry place, away from direct sunlight and extreme temperatures, following the manufacturer’s guidelines to preserve its integrity until use.
What regulatory approval does the Exaflex Impression Material hold?
The Exaflex Impression Material holds an FDA 510(k) clearance (K812406) under the Traditional pathway, with a decision date of October 6, 1981. This clearance confirms that the device meets FDA standards for safety and effectiveness as a dental impression material. The product is classified under FDA regulation 872.3660 and falls under the product code ELW.
Are there different sizes or models of the Exaflex Impression Material?
The Exaflex Impression Material is available in multiple lot numbers, each corresponding to specific formulations or packaging sizes tailored for various dental procedures. While the exact sizes or models are not detailed in the specifications, the variety of lot numbers suggests flexibility to accommodate different clinical needs, such as varying impression volumes or patient anatomies. For precise selection, refer to the manufacturer’s product catalog or technical documentation.