(84 days)
The MK-dent® Low Speed Handpieces are dental handpieces for use by a trained professional in general dentistry.
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.
The provided text describes a 510(k) summary for the MK-dent Low Speed Handpieces and Accessories. However, it does not contain information regarding the acceptance criteria, specific studies, or performance metrics that would typically be found for a device requiring performance evaluation for 510(k clearance.
This document focuses on establishing substantial equivalence for a Class I dental handpiece, meaning the device's acceptable performance is largely derived from its similarity to existing, legally marketed predicate devices, and adherence to recognized standards.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not present in this type of submission.
Here's a breakdown of what can be extracted and what information is missing:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Shares virtually all specifications and design characteristics with predicate device (A-dec/W&H Synea Low Speed (K993526)). | The MK-dent® Low Speed Handpiece shares virtually all specifications and design characteristics with the predicate device. Materials are of the same specifications to ensure biocompatibility. |
| Biocompatibility | Constructed of materials of the same specifications as the predicate device. | Materials of the same specifications as the predicate device (MK-dent® High Speed Dental Handpiece K021250, K032234) were used to ensure biocompatibility. |
| Sterilization | Ability to repeatedly adequately sterilize the device. | Confirmed by validation protocol. (No specific sterility assurance level (SAL) or organism reduction specified in this summary). |
| Voluntary Standard Compliance | Conformance to ISO Standard 7785-2 (Low speed dental handpieces) | Device conforms to ISO Standard 7785-2. |
| Conformance to ISO Standard 1797 (Shank dimensions) | Device conforms to ISO Standard 1797. | |
| Conformance to ISO Standard 3964 (Coupling device) | Device conforms to ISO Standard 3964. | |
| Conformance to ISO Standard 27785 (Water coolant) | Device conforms to ISO Standard 27785. | |
| Conformance to ISO Standard 1797 (Spindle strength) | Device conforms to ISO Standard 1797. |
Missing Information: For this device, the "performance" is largely demonstrated by meeting existing international standards and being equivalent in design and materials to a predicate. There are no quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or specific mechanical endurance values) reported in this summary beyond the general statement of conformance to standards.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not mentioned. This submission does not describe a clinical performance study with a test set of data. The "study" mentioned is focused on compliance with standards and a sterilization validation protocol.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not mentioned. This type of information is not relevant for this Class I device submission, which doesn't involve complex image analysis or diagnostic claims requiring expert adjudication.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable/Not mentioned. This device is a mechanical dental handpiece, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable/Not mentioned. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not mentioned as a "ground truth" in the clinical sense. The "ground truth" for this device's acceptance is its adherence to international standards (ISO) and demonstrable substantial equivalence to a predicate device, as well as validated sterilization protocols.
8. The sample size for the training set
- Not applicable/Not mentioned. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable/Not mentioned.
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| 510(k) Summary of safety and effectiveness | |
|---|---|
| Applicant: | MK-dent GmbHEichenweg 7B22941 Bargteheide, Germany |
| Contact: | Dr. Martina G nderothC.R.C. Partnerschaftsgesellschaft - Hamburg OfficeChristian-Koch-Weg 522399 Hamburg, GermanyPhone: +49 40 602 8585 / Fax: +49 40 606 79 577Email: mguenderoth@onlinehome.de |
| Device Name: | MK-dent*1) Low Speed Handpieces and Acessoriesincluding Spare Parts, Tubings, and Light PowerSystemModels: LS 2011, LS 2011L, LS 1011, LS 3011L, LS4011L, LS 5011L, LS 3011, LS 4011, LS 5011Heads: LS 9011, LS 9012, LS 9013, LS 9021, LS9021, LS 9031, LS 9111, LS 9112, LS 9211, LS9212, LS 9213, LS 9214, LS 9215Motors: 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 |
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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
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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.
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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 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
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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_________________________________________________________________________________________________________________________________________________________________
Page __ 1_ of __ 1_
§ 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.