FDA 510(k)

DEXIS Ti2 口腔传感器，DEXIS IXS 尺寸 1 口腔传感器，DEXIS IXS 尺寸 2 口腔传感器

K号: K233053 · 2023-11-21

申请人Dental Imaging Technologies Corporation

决定日期2023-11-21

产品代码MUH

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决定实质等同

器械摘要

DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Dental Imaging Technologies Corporation. It received FDA 510(k) clearance on 2023-11-21 under 510(k) number K233053. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor?

DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor is a medical device that received FDA 510(k) clearance on 2023-11-21. The listed applicant is Dental Imaging Technologies Corporation. The 510(k) number is K233053.

When did DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor receive FDA 510(k) clearance?

DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor received FDA 510(k) clearance on 2023-11-21, under 510(k) number K233053.

Who is the listed applicant for DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor?

The FDA 510(k) record lists Dental Imaging Technologies Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor?

The FDA product code for DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor is MUH.

列明Dental Imaging Technologies Corporation为申报人的其他记录

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