Identifiers
- 510(k) Number
- K200156 FDA 510(k)
- FDA Product Code
- EBF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3690 FDA 510(k)
- Regulation Number
- 872.3690 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a dental device, as indicated by the advisory committee classification. It is identified as substantially equivalent to a predicate device under the FDA 510(k) clearance process.
The device was cleared through the traditional 510(k) pathway, with the K number K200156. It is manufactured by Genoss Co., Ltd. and received FDA clearance on October 27, 2020.
Frequently asked questions
What is the Bright Low Flow device used for?
The Bright Low Flow is a dental device, as indicated by its advisory committee classification under product code EBF and review by the Dental advisory committee (DE), intended for dental applications as substantially equivalent to its predicate.
How was the Bright Low Flow device cleared for market?
The Bright Low Flow received FDA clearance through the traditional 510(k) pathway, with K number K200156, based on a determination of substantial equivalence to a predicate device, as confirmed by the decision code SESE and decision description 'Substantially Equivalent'.
Who manufactures the Bright Low Flow and where is it made?
The Bright Low Flow is manufactured by Genoss Co., Ltd., located at 1f, Gyeonggi R&Db Center, 105 Gwanggyo-Ro, Yeongtong-Gu, Suwon-Si, South Korea, with postal code 16229 and country code KR.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200156 | Class II | Active |
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Manufacturer
- Manufacturer
- GENOSS CO., Ltd.
Sources (1)
- FDA 510(k) K200156 24 fields · synced Sep 21, 2026