(73 days)
K 760929, K 021250
Not Found
No
The summary describes a standard air-powered dental handpiece with minor design changes for convenience, and explicitly states no mention of AI, DNN, or ML.
No.
The device is a dental handpiece used by professionals for general dentistry, which is a tool for procedures, not a device providing therapy.
No
The device is described as an air-powered dental handpiece used for general dentistry, which is a tool for performing procedures rather than diagnosing conditions.
No
The device description explicitly states it is an "air-powered dental handpiece," which is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "an air-powered dental handpiece providing light through a glass optic rod for use by a trained professional in general dentistry." This describes a tool used directly on a patient for a dental procedure, not a device used to examine specimens (like blood, urine, or tissue) outside the body to diagnose a condition.
- Device Description: The description focuses on the mechanical and optical aspects of the handpiece, not on any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples, reagents, or any other typical characteristics of an IVD.
Therefore, this device falls under the category of a general dental instrument used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device is an air-powered dental handpiece providing light through a glass optic rod for use by a trained professional in general dentistry.
Product codes
76 EFB, EFB
Device Description
The MK-dent® HS Handpiece shares virtually all specifications and design characteristics of the predicate devices. This was done intentionally by the designers and engineers. Only few minor changes implemented to the predicate device make the MKdent® Handpiece more convenient to use but do not affect the performance, safety or effectiveness of it.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professional in general dentistry
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
K 760929, K 021250
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
| OCT - 2 2003 510(k) Summary of safety and effectiveness | ||
|---|---|---|
| Applicant: | MK-dent GmbH | |
| Eichenweg 7B | ||
| 22941 Bargteheide, Germany | K032234 | |
| Contact: | Dr. Martina Günderoth | |
| C.R.C. Partnerschaftsgesellschaft | ||
| Katharinenstr. 5 | ||
| 23554 Lübeck, Germany | ||
| Phone: +49 (451) 388 2864 / Fax: +49 (451) 388 2867 | ||
| Email: crc@crc-online.de | ||
| Device Name: | MK-dent® High Speed Dental Handpiece, Models HS4021K, | |
| HS4011K, HS4012K, HS6021K, HS6011K, and HS6012K | ||
| Common Name: | Handpiece, air-powered, dental | |
| Classification Name: | Dental handpiece | |
| Device Class: | Class I | |
| Product Code: | 76 EFB | |
| Code of Federal Regulations: | 21 CFR 872.4200 | |
| Indications for Use: | The device is an air-powered dental handpiece providing light | |
| through a glass optic rod for use by a trained professional in | ||
| general dentistry |
Predicate Device Name: KaVo Dental Handpiece, Series 630 and 640 (K 760929) MK-dent® High Speed Dental Handpiece (K 021250)
Description of Device:
The MK-dent® HS Handpiece shares virtually all specifications and design characteristics of the predicate devices. This was done intentionally by the designers and engineers. Only few minor changes implemented to the predicate device make the MKdent® Handpiece more convenient to use but do not affect the performance, safety or effectiveness of it.
Substantially Equivalence - Safety and Effectiveness:
In all respects, the MK-dent® Handpiece is substantially equivalent to one or more airpowered dental handpieces currently marketed in the USA. The handpiece is constructed of materials of the same specifications as the predicate device to ensure biocompatibility. The handpiece conforms to applicable ISO standards. The ability to repeatedly adequately sterilize the device has been confirmed by validation protocol.
1
Voluntary standard compliance:
- ISO Standard 7785-1: High speed dental turbines
- ISO Standard 1797: Shank dimensions
- ISO Standard 3964: Coupling device
- ISO Standard 27785: Sound level
- ISO Standard 27785: Water coolant
- ISO Standard 1797: Spindle strength
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of three abstract shapes that resemble a stylized human figure or a bird in flight. The overall design is simple and recognizable, representing the department's mission and identity.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 2 2003
MK-Dent Gmbh C/O Dr. Martina Gunderoth C.R.C. Partherschaftsgesellschaft Katharinenstr. 5 23554 Lubeck, Germany
Re: K032234
Trade/Device Name: MK-Dent High Speed Dental Handpiece, Models HS4021k KS4011K, HS4012K, HS6021K, HS6011K, and HS6012K Regulation Number: 872.4200 Regulation Name: Dental handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: June 24, 2003 Received: July 21, 2003
Dear Dr. Gunderroth:
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 vour device 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.
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Page 2 - Dr. Gunderoth
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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product 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 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Susan Runner
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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3. Indications for Use
510(k) Number K032234
Device Name: MK-dent® High Speed Handpiece, Models HS 4021 K, HS 4011 K, HS 4012 K, HS 6021 K, HS 6011 K, and HS 6012 K
Indications for Use: The device is an air-powered dental handpiece providing light through a glass optic rod for use by a trained professional in general dentistry.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Pein Muluy for MSR
510(k) Number. K 032234
Prescription Use OR (Per 21 CFR 801.109)
Over the Counter Use