(85 days)
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
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.
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:
- A table of acceptance criteria and the reported device performance: No specific performance criteria or results are detailed.
- Sample size used for the test set and the data provenance: No test studies are described.
- 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.
- Adjudication method: Not applicable as no test set or ground truth establishment is detailed.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not mentioned.
- 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.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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NAME & ADDRESS:
NOV 0 8 2001
West College Avenue PA 17405-0872 P. J. Lehn Telefax
KD12720
P. Jeffery Lehn CONTACT:
August 14, 2001 DATE PREPARED:
TULSA CONTRA ANGLES TRADE OR PROPRIETARY NAME:
Dental handpieces and accessories (872.4200) CLASSIFICATION NAME:
K944719 W&H Series 100 Low Speed PREDICATE DEVICES:
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.
INTENDED USE: TULSA 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 Models TUL-8M / TUL16MT - Mechanical root canal preparation with rotating files
TECHNOLOGICAL CHARACTERISTICS: TULSA CONTRA ANGLES are substantially equivalent to those marketed under K944719. They have the same basic technology, primary energy source, and materials as the predicate device.
There are no materials in these contra angles that pose any potential for possible biocompatibility hazard. All of the materials of construction, which come into contact with the patient, are chromium-plated stainless steel.
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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 82001
Mr. P. Jeffrey Lehn Corporate Compliance Dentsply International 570 West College Avenue York, Pennsylvania 17404
Re: K012720
Trade/Device Name: Tulsa Contra Angles Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: August 14, 2001 Received: August 15, 2001
Dear Mr. Lehn:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 11 ), vice can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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Page 2 -- Mr. Lehn
You must comply with all the Act's requirements, including, but not limited to: registration Touring (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice alle listing (21 CF R Part 807), and ity systems (QS) regulation (21 CFR Part 820); and if requirences as bet form in arouv t radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section This letter will and w you to began inaling of substantial equivalence of your device to 9 reqs) premained nevice results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 If you desire specific as not 10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Patricia Cucenitfor
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
(As Required by 21 CFR 807.87(e)
NOV 0 82001
510(K) Number (if known):
TULSA CONTRA ANGLES Device Name:
Indications for 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
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Suzu Runne
(Division Sign-Off)
Sign-om)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number. K012720
§ 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.