Bright Temporary C&B
510(k) K192830
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK192830 | Date2 Sep 2020 | 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- Withdrawn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
- EBG
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3770
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
Bright Temporary C&B is a self-curing, moldable composite material classified as a dental temporary crown and bridge restoration. It is designed for constructing provisional restorations in dentistry, offering aesthetic and mechanical properties suitable for temporary restorative needs. The material is formulated to provide durability and a natural appearance during the interim period before permanent restorations are placed.
Bright Temporary C&B is supplied in three mixing ratios (1:1, 4:1, and 10:1) to accommodate varying clinical requirements. It is intended for single-use applications and requires proper handling and storage as per manufacturer guidelines. The device holds an FDA 510(k) clearance under the product code EBG, with a decision classification of Substantially Equivalent to a predicate device. No additional regulatory status beyond the stated FDA clearance is implied.
From the manufacturer
Bright Temporary C&B is a self-curing, moldable composite designated for the construction of temporary crown and bridge restorations, available in three different ratios (1:1, 4:1, 10:1). It offers an excellent aesthetic result and in combination with its optimal mechanical properties is an ideal tool for fabricating provisional restorations.
Other devices from Dmp Dental Industry S.A.
Questions
AI-generated answers, 1 Oct 2026
What is Bright Temporary C&B used for in dentistry?
Bright Temporary C&B is a self-curing, moldable composite material specifically designed for constructing provisional crown and bridge restorations. It provides both aesthetic and mechanical properties to ensure stability and a natural appearance during the interim period before permanent restorations are placed. This makes it ideal for temporary restorative needs in dentistry.
How is Bright Temporary C&B supplied, and what mixing ratios are available?
Bright Temporary C&B is supplied in three distinct mixing ratios: 1:1, 4:1, and 10:1. These ratios allow clinicians to tailor the material’s consistency and working properties to match specific clinical requirements, ensuring optimal handling and performance for different provisional restoration scenarios.
Is Bright Temporary C&B intended for single-use or reusable applications?
Bright Temporary C&B is explicitly designed for single-use applications. This ensures patient safety and hygiene, as the material is not intended to be reused after clinical use. Proper handling and adherence to manufacturer guidelines are essential to maintain sterility and performance.
What regulatory clearance does Bright Temporary C&B hold?
Bright Temporary C&B holds FDA 510(k) clearance under product code EBG, with a decision classification of Substantially Equivalent (SESE) to a predicate device. This clearance confirms that the device meets regulatory standards for dental temporary crown and bridge restorations, ensuring its safety and effectiveness for intended use.
How should Bright Temporary C&B be stored to maintain its properties?
Bright Temporary C&B should be stored according to the manufacturer’s guidelines to preserve its self-curing properties and working consistency. Proper storage conditions—typically in a cool, dry place away from direct sunlight—help prevent degradation and ensure the material remains effective for clinical use when needed.