LC ResinCal PC
by S&C Polymer Silicon- Und Composite Spezialitaten GmbH 510(k)
Active
510(k) K202413
Overview
The LC ResinCal PC is a Liner, Cavity, Calcium Hydroxide (per OpenFDA classification), designed for dental applications. This material is intended for use as a protective base or liner in dental cavities, providing a calcium hydroxide barrier to promote healing and reduce postoperative sensitivity. Its formulation supports pulp protection and aids in the remineralization of dentin during restorative procedures.
Supplied as a single-use dental resin liner, the LC ResinCal PC is intended for professional use in dental offices. It is classified as a Class II medical device under FDA regulations and has received FDA 510K clearance through a traditional review process. The product is packaged for sterile application and must be handled in accordance with standard dental infection control protocols. No MRI safety considerations are specified, and storage should follow manufacturer guidelines to maintain integrity until use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK202413 | Date20 Nov 2020 | 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- Withdrawn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
- EJK
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3250
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Other devices from S&C Polymer Silicon- Und Composite Spezialitaten GmbH
Questions
What is the LC ResinCal PC used for in dental procedures?
The LC ResinCal PC is a calcium hydroxide dental liner designed to act as a protective barrier in cavities. It promotes pulp protection and aids in dentin remineralization during restorative treatments, helping to reduce postoperative sensitivity and support healing.
Is the LC ResinCal PC intended for single-use or reuse?
The LC ResinCal PC is explicitly supplied as a single-use dental resin liner. This ensures sterility and infection control, as it must be handled according to standard dental protocols. Reuse is not recommended or supported by the manufacturer.
How is the LC ResinCal PC packaged and stored?
The LC ResinCal PC is packaged sterile for professional dental office use. Storage should follow manufacturer guidelines to maintain its integrity until application. Avoid exposure to moisture or extreme temperatures, as this could compromise its performance.
Does the LC ResinCal PC require any special handling or safety considerations?
The product is sterile and designed for single-use in controlled dental environments. While no MRI safety considerations are specified, it must be handled using standard dental infection control protocols. Always adhere to the manufacturer’s instructions for optimal results.
What regulatory approval does the LC ResinCal PC hold?
The LC ResinCal PC has received FDA 510(k) clearance through a traditional review process, confirming its substantial equivalence to predicate devices. It is classified as a Class II medical device under FDA regulations, ensuring compliance with dental safety and performance standards.