Silicone Elastomer Kit
by Rapid Injection Systems Corp.
510(k) K810869
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK810869 | Date29 Apr 1981 | 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- Withdrawn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, 19 Sep 2026
The Silicone Elastomer Kit is a dental device classified under Resin, Denture, Relining, Repairing, Rebasing, designed for modifying or repairing denture bases. It consists of silicone elastomer materials intended to provide a flexible, durable alternative for relining or repairing dentures in clinical settings.
This kit is supplied as a single-use dental material and is regulated under FDA 510(k) clearance (K810869) with a Traditional clearance type, filed under the Dental advisory committee. It is intended for use in dental laboratories or clinics and must be handled according to manufacturer guidelines for proper application and curing. No additional regulatory status beyond the stated FDA clearance is implied.
Other devices from Rapid Injection Systems Corp.
Questions
AI-generated answers, 19 Sep 2026
What clinical situations is the Silicone Elastomer Kit designed to address in denture care?
The Silicone Elastomer Kit is specifically formulated for modifying or repairing denture bases, offering a flexible and durable solution. It is intended for relining or repairing dentures when adjustments are needed due to wear, changes in the patient’s mouth anatomy, or damage. This kit provides an alternative to traditional resin-based materials, particularly where a softer, more adaptable material is preferred for patient comfort or function.
Is the Silicone Elastomer Kit meant for repeated use on multiple patients, or is it single-use?
The Silicone Elastomer Kit is explicitly supplied as a single-use dental material. This means each kit is intended for one application per patient to maintain sterility and clinical safety. Reusing the kit could compromise its performance and introduce contamination risks, so adherence to single-use guidelines is critical.
How should the Silicone Elastomer Kit be stored to ensure it remains effective for its intended use?
While the exact storage instructions are provided by the manufacturer, silicone elastomer materials like this kit typically require protection from extreme temperatures, moisture, and direct sunlight. The kit should be stored in a cool, dry environment—preferably within its sealed packaging—until ready for use. Improper storage could affect the material’s flexibility, curing properties, or shelf life.
What regulatory pathway was followed for FDA clearance of this kit, and what does that mean for dental professionals?
The Silicone Elastomer Kit received FDA 510(k) clearance under the Dental advisory committee (DE), with a classification of *Substantially Equivalent* (SESE) to a predicate device. This means the FDA determined it meets the same performance standards as an existing approved device and is safe and effective for its intended use—relining or repairing denture bases. Dental professionals can rely on this clearance as evidence of the kit’s regulatory compliance for clinical applications.