(84 days)
Not Found
No
The summary describes a mechanical dental handpiece with variations in design and features like light. There is no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a dental handpiece used for general dentistry procedures, which are typically restorative or operative, not therapeutic in the sense of treating a disease or condition therapeutically.
No
The MK-dent® Low Speed Handpieces are described as dental handpieces for use in general dentistry, which are tools used for treatment (e.g., cutting, drilling) rather than for diagnosing a condition.
No
The device description clearly states it is a dental handpiece, which is a physical hardware device used in dentistry.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "use by a trained professional in general dentistry." This indicates a direct interaction with the patient's oral cavity for dental procedures, not for testing samples outside the body.
- Device Description: The description details a dental handpiece used for mechanical work (like drilling or polishing) within the mouth. This is a therapeutic or procedural device, not a diagnostic one.
- Lack of IVD Characteristics: The description does not mention any components or functions related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This dental handpiece does not fit that description.
N/A
Intended Use / Indications for Use
The MK-dent® Low Speed Handpieces are dental handpieces for use by a trained professional in general dentistry.
Product codes (comma separated list FDA assigned to the subject device)
76 EFB
Device Description
The MK-dent® Low Speed Handpieces are compatible to air and electric drives. The handpieces are available in several versions. For example, the LS 2011L is an angled handpiece providing light through a glass optic rod, the LS 2001 has no glass optic rod, and the LS1011 is non-angled.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
| 510(k) Summary of safety and effectiveness | |
|---|---|
| Applicant: | MK-dent GmbH |
| Eichenweg 7B | |
| 22941 Bargteheide, Germany | |
| Contact: | Dr. Martina G nderoth |
| C.R.C. Partnerschaftsgesellschaft - Hamburg Office | |
| Christian-Koch-Weg 5 | |
| 22399 Hamburg, Germany | |
| Phone: +49 40 602 8585 / Fax: +49 40 606 79 577 | |
| Email: mguenderoth@onlinehome.de | |
| Device Name: | MK-dent*1) Low Speed Handpieces and Acessories |
| including Spare Parts, Tubings, and Light Power | |
| System | |
| Models: LS 2011, LS 2011L, LS 1011, LS 3011L, LS | |
| 4011L, LS 5011L, LS 3011, LS 4011, LS 5011 | |
| Heads: LS 9011, LS 9012, LS 9013, LS 9021, LS | |
| 9021, LS 9031, LS 9111, LS 9112, LS 9211, LS | |
| 9212, LS 9213, LS 9214, LS 9215 | |
| Motors: AM 2011, AM 2012 | |
| Common Name: | Handpiece, low speed, dental |
| Classification Name: | Dental handpiece and accessories |
| Device Class: | Class I |
| Product Code: | 76 EFB |
| Code of Federal Regulations: | 21 CFR 872.4200 |
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| Indications for Use: | The MK-dent® Low Speed Handpieces are dental handpieces for use by a trained professional in general dentistry. |
|---|---|
| Predicate Device Name: | A-dec/W&H Synea Low Speed (K993526); with respect to used materials: MK-dent® High Speed Dental Handpiece (K 021250, K032234) |
| Description of Device: | The MK-dent® Low Speed Handpieces are compatible to air and electric drives. The handpieces are available in several versions. For example, the LS 2011L is an angled handpiece providing light through a glass optic rod, the LS 2001 has no glass optic rod, and the LS1011 is non-angled. |
| Substantially Equivalence - Safety and Effectiveness: | The MK-dent® Low Speed Handpiece shares virtually all specifications and design characteristics of the predicate device. It is therefore substantially equivalent to one or more dental handpieces currently marketed in the USA. The handpiece is constructed of materials of the same specifications as the predicate device to ensure biocompatibility. |
| Compared to the predicate the only design change refers to the division of the head from the handpiece. This change does not affect the performance but makes the handpiece more conveniant to use, as the heads may easily be exchanged |
2
The handpiece conforms to applicable ISO standards. The ability to repeatedly adequately sterilize the device has been confirmed by validation protocol.
Voluntary standard compliance:
- ISO Standard 7785-2: Low speed dental handpieces
- ISO Standard 1797: Shank dimensions
- ISO Standard 3964: Coupling device
- ISO Standard 27785: Water coolant
- ISO Standard 1797: Spindle strength
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 3 - 2005
MK-DENT GMBH C/O Dr. Martina Gunderoth, MBA C.R.C. - Hamburg Office Christian-Koch-Weg 5 Hamburg, GERMANY 22399
Re: K051872
Trade/Device Name: MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPA Regulation Number: 21 CFR 872.4200 Regulation Name: Dental handpiece and accessories Regulatory Class: I Product Code: EFB Dated: June 29, 2005 Received: July 19, 2005
Dear Dr. Gunderoth:
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 your 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.
4
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 your 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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours,
Cluts
Chia-Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center of Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known) ___K051872
Device Name'. MK-dent @ Low Speed Handpieces and Acessories (including Spare parts, Tubings and Light Power System),
ings and Light Power System);
LS 2011, LS 2011L, LS 1011 , LS 3011L, LS 4011L, LS 5011L, LS 3011, Models: LS 4011, L.S 5011
LS 9011, LS 9012, LS 9013, LS 9013, LS 9021, LS 9021, LS 9031, LS 90111, Heads: LS 9112, LS 9211, LS 9212, LS 9213, LS 9214, LS 9215
LS 9112, LS 9211, LS 8212, LS 6212, LS 2011, LS 2011L and LS 1011 Motors:
Indications for Use:
:
The device is a low speed dental handpiece for use by a trained professional in general dentistry.
1 AND/OR Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
MSR
(Division Sıgn-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
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