G-Cera Orbit Colour Communication Set
510(k) K932039
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK932039 | Date8 Jul 1993 | 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- Withdrawn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
- EIH
- FDA applicant
- GC America, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 872.6660
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The G-Cera Orbit Colour Communication Set is a dental device designed for porcelain staining in restorative dentistry. It consists of a system of powders and materials used to achieve precise colour matching and communication of shade information between dental professionals during the fabrication of porcelain restorations. This aids in ensuring consistent aesthetic outcomes in dental prosthetics.
The set is supplied as a reusable system for use in dental laboratories and clinics. It is intended for single-use applications per the manufacturer’s instructions, though the specific sterility requirements are not detailed in the regulatory data. The device falls under FDA classification EIH (Powder, Porcelain) and was granted a 510(k) clearance under the Dental advisory committee in 1993. No third-party review was conducted, and the device is classified as Class II.
Other devices from Gc America Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the G-Cera Orbit Colour Communication Set used for?
The G-Cera Orbit Colour Communication Set is designed specifically for porcelain staining in restorative dentistry. It helps dental professionals achieve precise colour matching and effectively communicate shade information during the fabrication of porcelain restorations. This ensures consistent and accurate aesthetic outcomes in dental prosthetics, reducing discrepancies between the planned shade and the final restoration.
How is the G-Cera Orbit Colour Communication Set supplied, and is it reusable?
The set is supplied as a reusable system intended for use in dental laboratories and clinics. While the system itself is reusable, it is meant for single-use applications per the manufacturer’s instructions for each porcelain staining procedure. This ensures hygiene and accuracy in shade communication for each restoration.
Is sterility a requirement for the G-Cera Orbit Colour Communication Set?
The regulatory data does not explicitly detail sterility requirements for the G-Cera Orbit Colour Communication Set. However, since it is used in clinical and laboratory settings for porcelain staining, adherence to standard dental hygiene protocols—such as cleaning and disinfection between uses—is recommended to maintain safety and prevent cross-contamination.
What regulatory pathway was followed for the G-Cera Orbit Colour Communication Set?
The G-Cera Orbit Colour Communication Set was granted FDA 510(k) clearance under the Dental advisory committee in 1993. It was classified as substantially equivalent (SESE) to a predicate device and falls under the product code EIH (Powder, Porcelain). The clearance was granted through a traditional review process without third-party involvement, and the device is classified as Class II.
Can this set be used for both in-clinic and laboratory applications?
Yes, the G-Cera Orbit Colour Communication Set is explicitly designed for use in both dental laboratories and clinics. Its reusable system and precise colour-matching tools make it versatile for environments where porcelain restorations are fabricated and finalized, ensuring consistency in shade communication across different settings.