Loving Touch LT:200 Ultrasonic Scaler

No FDA recalls found in the data synced 22 Oct 2026.

Full name

LT:200, Loving Touch

510(k) Number

K761247 ↗

FDA Product Code

ELC

Device Class

Class II

Regulation

21 CFR Part 872.4850

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• HU:500, Hygienassist

  Class I

  FDA 510(k) K771251 Active Cleared 15 Jul 1977

• Turbine, Air Driven Handpiece (2000)

  Class I

  FDA 510(k) K760331 Active Cleared 11 Aug 1976

• Masterscale II

  Class II

  FDA 510(k) K791704 Active Cleared 26 Oct 1979

• Ultrasonic Dental Prophylaxis Unit

  Class II

  FDA 510(k) K791024 Active Cleared 17 Sep 1979

• CB600, Turbine Control Bol

  Class I

  FDA 510(k) K771252 Active Cleared 15 Jul 1977

• Illuminated Dental Handpiece

  Class I

  FDA 510(k) K772244 Active Cleared 20 Jan 1978

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• What is the primary purpose of the LT:200 Loving Touch Ultrasonic Scaler in dental procedures?

  The LT:200 Loving Touch is designed specifically for removing plaque, calculus, and biofilm from teeth and dental implants. It uses high-frequency vibrations to disrupt and emulsify hard and soft deposits, making it effective for periodontal therapy and maintaining oral hygiene in dental offices and clinics.

• Is the LT:200 Loving Touch supplied sterile, and how should it be prepared for use?

  The LT:200 is not sterile upon delivery. It is a reusable instrument that must be thoroughly cleaned, disinfected, and sterilized between each use to ensure patient safety and device longevity.

• What regulatory pathway was followed for FDA clearance of the LT:200, and what does that mean for its equivalence to other devices?

  The LT:200 received FDA clearance via the 510(k) Traditional pathway and was classified as Substantially Equivalent (SESE) to predicate devices. This means the FDA determined it has the same intended use and technological characteristics as legally marketed competing or comparable devices, ensuring it meets established safety and effectiveness standards.

• Are there multiple models or sizes available for the LT:200, or is it a single-unit device?

  The provided data does not specify distinct models or sizes for the LT:200, but the product code (ELC) and registration numbers indicate it is listed under the Ultrasonic Scaler category with multiple associated FEI numbers. This suggests it may be part of a broader product line or have variations in accessories or attachments, though the core device itself appears standardized for ultrasonic scaling.

• How should the LT:200 be stored, and are there any special handling instructions?

  While the data does not detail storage conditions explicitly, as a reusable medical device, the LT:200 should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. After use, it must be properly cleaned and maintained to prevent corrosion or damage, ensuring it remains functional for subsequent procedures.