Caulk Tylok
by L.D. Caulk Co. 510(k)
Active
510(k) K780301
Overview
The Caulk Tylok is a dental cement, classified under the nomenclature for restorative dental materials. It is designed to provide a durable, adhesive seal in dental restorations, ensuring structural integrity and preventing microleakage at the tooth-restoration interface.
This device is supplied as a reusable dental material and is regulated under FDA 510(k) clearance (K780301) with a decision of Substantially Equivalent. It is intended for use in clinical dental settings, adhering to regulatory standards for Class II medical devices. No additional sterility or MRI safety information is specified in the data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK780301 | Date28 Feb 1978 | 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- Withdrawn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
- EMA
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3275
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Other devices from L.D. Caulk Co.
Questions
What is the primary purpose of the Caulk Tylok dental cement in clinical settings?
The Caulk Tylok is designed as a dental cement to create a durable, adhesive seal in dental restorations. Its main function is to ensure structural integrity at the tooth-restoration interface while preventing microleakage, which helps maintain the longevity and effectiveness of the restoration.
Is the Caulk Tylok intended for single-use or reusable applications in a dental clinic?
The Caulk Tylok is explicitly described as a reusable dental material. This means it can be used multiple times in clinical settings, provided it adheres to proper sterilization and handling protocols.
How is the regulatory status of the Caulk Tylok determined, and what does that mean for its use?
The Caulk Tylok received FDA 510(k) clearance (K780301) with a decision labeled *Substantially Equivalent*, meaning it was deemed comparable to a legally marketed predicate device. This classification places it under Class II medical device regulations, ensuring it meets established safety and effectiveness standards for dental restorative materials in clinical use.
Are there any specific storage or handling requirements mentioned for the Caulk Tylok?
The provided data does not specify any particular storage conditions (e.g., temperature, humidity) or handling instructions beyond its classification as a reusable dental material. Clinicians should follow standard dental protocols for storage and reuse to maintain sterility and performance.