FDA Clears Dental X-Ray System from Changzhou Boen Zhongding Medical Technology

FDA 510(k) clearance granted to Changzhou Boen Zhongding Medical Technology (China) for a dental X-ray system under product code OAS. No clinical performance data reported in clearance notice.

• 510(k) clearance (K250839) for a dental X-ray imaging system; product code OAS covers intraoral dental X-ray devices.
• Manufacturer is Changzhou Boen Zhongding Medical Technology Co., Ltd., a Chinese medical device maker entering the FDA-cleared dental imaging market.
• No predicate device, sensitivity/specificity, or performance benchmarks were reported in the clearance summary available from the source.

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