Conversil FL and Conversil P
510(k) K913583
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK913583 | Date13 Nov 1991 | 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- Withdrawn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
- ELW
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3660
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a dental impression material. It is substantially equivalent to a predicate device and was cleared through the traditional 510(k) pathway.
The device is supplied by Wilde-USA, Inc. and is intended for use in dental settings. It is a Class II medical device with product code ELW and regulation number 872.3660.
Other devices from Wilde-USA, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Conversil FL and P dental impression material used for?
The Conversil FL and P is a dental impression material intended for use in dental settings to create accurate impressions of teeth and oral tissues for various dental procedures.
How is the Conversil FL and P dental impression material supplied?
The device is supplied by Wilde-USA, Inc. and is available as a Class II medical device with product code ELW, though specific packaging details are not provided in the device data.
Is the Conversil FL and P dental impression material single-use or reusable?
The device data does not specify whether the Conversil FL and P dental impression material is designed for single-use or multiple uses, so this information would need to be obtained directly from the manufacturer.
What is the regulatory status of the Conversil FL and P dental impression material?
The Conversil FL and P dental impression material has FDA 510(k) clearance with number K913583, indicating it is substantially equivalent to a predicate device and was cleared through the traditional 510(k) pathway.