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K Number
K201317
Device Name
TTBIO EVOCLEAN Ultrasonic Scaler
Manufacturer
TTBIO CORP.
Date Cleared
2020-12-04

(200 days)

Product Code
ELC
Regulation Number
872.4850
Type
Traditional
Panel
DE
Reference & Predicate Devices
K052028
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

TTBIO EVOCLEAN Ultrasonic Scaler is designed for use during dental cleaning and periodontal debridement of periodontal diseases.

Device Description

TTBIO EVOCLEAN Ultrasonic Scaler consists of an ultrasonic generator, a handpiece, a power supply, a foot pedal and other minor accessories. There are two models of TTBIO EVOCLEAN Ultrasonic Scaler, one is EVOCLEAN and the other is EVOCLEAN+. The specifications of these two models are almost the same; the major difference is the connection type, fix and plug in, between the handpiece and main unit. TTBIO EVOCLEAN Ultrasonic Scaler uses ultrasonic energy to generate mechanical micro-vibration of the available inserts to perform the dental procedures defined in its intended use. TTBIO EVOCLEAN Ultrasonic Scaler is a multi-frequency available device which is compatible with 25 KHz or 30 KHz inserts. The system will automatically detect the insert oscillation frequency, need not to operate it manually. The handpiece is connected directly to the device's ultrasonic generator, from which it receives the functional drive signals, search and locate the resonant frequency of the insert, which varies according to the insert in use.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the TTBIO EVOCLEAN Ultrasonic Scaler. It does not contain information about an AI-powered device or a study involving human readers and AI assistance for diagnostic purposes. Instead, it details the substantial equivalence of an ultrasonic scaler to a predicate device, focusing on non-clinical performance and testing. Therefore, I cannot generate a response that includes acceptance criteria and a study proving an AI device meets those criteria based on the provided text.

Specifically, the document focuses on the following:

  • Device identification: TTBIO EVOCLEAN Ultrasonic Scaler (K201317)
  • Regulatory classification: Class II, Product Code ELC
  • Intended Use: Dental cleaning and periodontal debridement.
  • Comparison to predicate device (BONART ART-M3II Ultrasonic Scaler UNITS WITH ACCESSORIES, K052028): Demonstrates substantial equivalence through detailed comparisons of indications for use, contraindications, components, materials, treatment mechanism, power, frequency, etc.
  • Non-clinical testing: Refers to testing according to ISO18397:2016, cleaning validation, biocompatibility evaluation (ISO 10993-1), software verification/validation, and electrical safety/EMC testing (IEC 60601-1-2:2014 and ANSI/AAMI ES60601-1:2005/(R)2012 & A1:2012).
  • Absence of clinical testing: Explicitly states "No clinical testing was conducted for this submission."

Since the request is about acceptance criteria and a study for an AI device and the provided text is for an ultrasonic scaler with no AI component, I cannot fulfill the request directly.

§ 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.