Identifiers
- 510(k) Number
- K143667 FDA 510(k)
- FDA Product Code
- DYH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3750 FDA 510(k)
- Regulation Number
- 872.3750 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Gc Kommonbase is a dental material used to fabricate a resin base or understructure for bracket placement. It features a large bonding base that provides precise bracket fit and positioning, while maximizing bond strength.
The Gc Kommonbase is supplied as a dental device and is regulated under the product code DYH. It has been authorized by the FDA under the 510K clearance type, with the regulation number 872.3750, and is intended for use in dental applications, specifically for fabricating resin base or understructure for bracket placement.
Frequently asked questions
What is the GC KommonBase used for?
The GC KommonBase is used to fabricate a resin base or understructure for bracket placement in dental applications, providing a precise bracket fit and maximizing bond strength.
How is the GC KommonBase supplied?
The GC KommonBase is supplied as a dental device, regulated under the product code DYH, and is intended for use in dental applications.
What is the regulatory status of the GC KommonBase?
The GC KommonBase has been authorized by the FDA under the 510K clearance type, with the regulation number 872.3750, and is classified as substantially equivalent.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: GC Kommonbase - GC Orthodontics Inc. - gcorthonline.com, Adhesives and Cements - GC KommonBase™ - GC Orthodontics Inc., GC KommonBase (K143667) — FDA 510 (k) | Innolitics, PDF 510K KommonBase FINAL - accessdata.fda.gov
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K143667 | Class II | Active |
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Manufacturer
- Manufacturer
- GC Orthodontics America Inc.
- FDA Applicant
- Gc Orthodontics America, Inc.
Sources (1)
- FDA 510(k) K143667 24 fields · synced Oct 1, 2026