TEM-STIK
by Coralite Dental Products, Inc.
510(k) K821824
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK821824 | Date6 Jul 1982 | 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- Withdrawn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
- EMA
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3275
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The TEM-STIK is a dental cement, classified under FDA regulation 872.3275. It is designed as a restorative material used in dental procedures to bond and fill cavities or repair dental structures, providing mechanical support and chemical resistance within the oral environment.
TEM-STIK is supplied as a reusable dental material and is intended for use in clinical dental settings. It is regulated under FDA 510(k) clearance (K821824) with a traditional clearance type, determined to be substantially equivalent to existing dental cements. The product is distributed by Coralite Dental Products, Inc., and adheres to dental specialty standards.
Questions
AI-generated answers, 20 Sep 2026
What is the primary use of the TEM-STIK dental cement in clinical practice?
TEM-STIK is designed as a restorative dental cement used to bond and fill cavities or repair dental structures. It provides mechanical support and chemical resistance within the oral environment, helping to restore function and integrity to treated teeth.
Is TEM-STIK intended for single-use or reusable applications in a dental setting?
TEM-STIK is explicitly described as a reusable dental material, meaning it can be used multiple times in clinical dental procedures. This distinguishes it from single-use materials, which are typically discarded after one application.
How is TEM-STIK regulated by the FDA, and what does its clearance status indicate?
TEM-STIK holds an FDA 510(k) clearance (K821824) under the classification 872.3275, categorized as a dental cement. The clearance is labeled as *substantially equivalent* to existing dental cements, meaning the FDA determined it performs similarly to legally marketed predecessors. This does not imply approval for specific clinical uses but confirms compliance with regulatory standards for dental restorative materials.
Where is TEM-STIK manufactured and distributed, and how can I verify its authenticity?
TEM-STIK is manufactured and distributed by Coralite Dental Products, Inc. based at 803 N. Front St. Suite 3, McHenry, IL 60050. While the data does not provide a direct verification method (like serial numbers or batch codes), purchasing directly from the manufacturer ensures authenticity. Always confirm the product’s registration numbers (e.g., 3012441963) match the label if sourcing from third parties.