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K Number
K012720
Device Name
TULSA CONTRA ANGLES
Manufacturer
DENTSPLY INTL.
Date Cleared
2001-11-08

(85 days)

Product Code
EFB
Regulation Number
872.4200
Type
Traditional
Panel
DE
Reference & Predicate Devices
K944719
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

These contra angles are designed to be used with dental motors for :

Model TUL-1: For endodontic procedures, removing carious material, reducing hard tooth structure, cavity preparations, finishing tooth preparations and restorations, and polishing teeth

Mechanical root canal preparation with Models TUL-8M and TUL16-MT: rotating files

Device Description

The TULSA CONTRA ANGLES are contra angle attachments to handpieces and are manufactured by W&H Dentalwerks GmbH for DENTSPLY Tulsa Dental as Models TUL-1, TUL-8M, and TUL-16MT. These contra angles are designed to transmit the rotational movement of the motor axle to the shank of a bur or file that will be inserted into the output end of the contra angle. These contra angles contain a coupling part fittable to dental motors with a coupling according to ISO 3964. The output ends of the handpieces contain chuck systems for accommodations of standardized bur and file shanks.

AI/ML Overview

The provided text does not contain information regarding acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) premarket notification letter from the FDA stating that the Tulsa Contra Angles device is substantially equivalent to legally marketed predicate devices. It outlines the device description, intended use, and technological characteristics, but it does not include detailed performance metrics or a study report with acceptance criteria.

While the document states that the device has the "same basic technology, primary energy source, and materials as the predicate device" (K944719 W&H Series 100 Low Speed), it doesn't quantify specific performance requirements or present data from tests to demonstrate adherence to such criteria.

Therefore, I cannot provide the requested information, including:

  1. A table of acceptance criteria and the reported device performance: No specific performance criteria or results are detailed.
  2. Sample size used for the test set and the data provenance: No test studies are described.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is mentioned.
  4. Adjudication method: Not applicable as no test set or ground truth establishment is detailed.
  5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not mentioned.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a mechanical dental device, not an AI algorithm.
  7. The type of ground truth used: Not applicable.
  8. The sample size for the training set: Not applicable.
  9. How the ground truth for the training set was established: Not applicable.

§ 872.4200 Dental handpiece and accessories.

(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.