Ultrasonic dental scaler超声波洁牙机 FDA

曾工 · 发表于 2022-4-29 18:29:04

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Ultrasonic dental scaler超声波洁牙机 FDA
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-872

CFR - Code of Federal Regulations Title 21

PART 872 -- DENTAL DEVICES

Subpart E - Surgical Devices

Sec. 872.4850 Ultrasonic scaler.
(a) Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.

(b) Classification. Class II.

Ultrasonic scaler - FDA

K201317.pdf (511.93 KB, 下载次数: 4)

K053578.pdf (104.97 KB, 下载次数: 7)

K070975.pdf (138.43 KB, 下载次数: 4)

K132322.pdf (199.42 KB, 下载次数: 4)

exemptions from section 510(k)

非医疗用途，非专业用途，可以豁免

exemptions from section 510(k)

曾工 · 发表于 2022-4-29 18:51:41

Non-clinical Testing:

The functions of TTBIO EVOCLEAN Ultrasonic Scaler were verified according to ISO18397:2016.

Cleaning validation testing is performed in accordance with recommended evaluations as listed in AAMI TIR30, AAMI TIR12, and Guidance for Industry and FDA Staff – Processing/Reprocessing Medical Devices in Health Care Settings.

The biocompatibility evaluation for TTBIO EVOCLEAN Ultrasonic Scaler was conducted in accordance with Guidance for Industry and FDA Staff – Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”.

Software verification and validation testing were conducted, and documentation was provided as recommended by FDA’s Guidance for Industry and FDA Staff, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices”.

EMC and Electrical safety testing comply with IEC 60601-1-2:2014 and ANSI/AAMI ES60601-1:2005/(R)2012 & A1:2012.

Clinical Testing:
No clinical testing was conducted for this submission.