Bistite II Sc
510(k) K991711
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK991711 | Date7 Jul 1999 | 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- Withdrawn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, 22 Sep 2026
The Bistite II Sc is a dental cement, classified as a class 2 device. It is designed for cementation of various dental materials, including precious and nonprecious metals, ceramics, and porcelain.
The Bistite II Sc is supplied with various components, including adhesive and primer. It is regulated under the FDA with a 510K clearance and is classified under regulation number 872.3275. The device is intended for use in dental applications, with specific instructions for use provided by the manufacturer.
Other devices from Tokuyama America, Inc.
Questions
AI-generated answers, 22 Sep 2026
What is the Bistite II Sc used for?
The Bistite II Sc is used for cementation of various dental materials, including precious and nonprecious metals, ceramics, and porcelain.
What components are included with the Bistite II Sc?
The Bistite II Sc is supplied with various components, including adhesive and primer.
Is the Bistite II Sc a single-use or reusable device?
The description does not specify whether the Bistite II Sc is single-use or reusable, but it is classified as a class 2 device.
What regulatory clearance does the Bistite II Sc have?
The Bistite II Sc has a 510K clearance from the FDA, with a regulation number of 872.3275.