Oral Matrix
K-Number: K231513 · 2024-02-16
Decision Date2024-02-16
Product CodeNPL
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Oral Matrix is a medical device manufactured by Beijing Biosis Healing Biolog Ical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-02-16 under approval number K231513. The device is classified under product code NPL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Oral Matrix?
Oral Matrix is a medical device that received FDA 510(k) clearance on 2024-02-16. It is manufactured by Beijing Biosis Healing Biolog Ical Technology Co., Ltd.. The 510(k) number is K231513.
When was Oral Matrix approved by the FDA?
Oral Matrix received FDA 510(k) clearance on 2024-02-16, under approval number K231513.
What company makes Oral Matrix?
Oral Matrix is manufactured by Beijing Biosis Healing Biolog Ical Technology Co., Ltd..
What is the FDA product code for Oral Matrix?
The FDA product code for Oral Matrix is NPL.
Other Devices by Beijing Biosis Healing Biolog Ical Technology Co., Ltd.
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K203622Medical Gloves
K201639Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads
K202844Medical Surgical Gowns
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.