(188 days)
The device is an air-powered dental handpiece for use by a trained professional in general dentistry.
The MK-dent® HS 2012/2014 shares virtually all specifications and design characteristics of the predicate devices. The only major design change refers to the strength of the auto chuck mechanism. By increasing the spring strength, we have created a more reliable version compared to KaVo 625. By increasing the bur retention strength from 6 lbs (as with the predicate device) to 8 lbs. (MK-dent® HS 2012/2014) we have been able to vastly reduce the odds of a bur prematurely ejecting from the handpiece. A few minor changes to the predicate device which do not affect the performance but we feel make the handpiece convenient to use are as follows: Reduction in the weight of the handpiece to 2 oz.. This reduces operator hand fatigue. Softening the knurling on the handle. This allows dirt, blood and salvia to be more easily removed from the body shell of the handpiece, thus allowing better conformity to sterilization procedures. It also provides better tactile sense to the operator while wearing gloves.
Here's an analysis of the provided text regarding the MK-dent® HS 2012/2014 dental handpiece, focusing on acceptance criteria and supporting studies:
This document is a 510(k) premarket notification for a Class I dental device, the MK-dent® HS 2012/2014. For Class I devices, the regulatory pathway often relies on demonstrating substantial equivalence to a legally marketed predicate device rather than extensive clinical efficacy studies typically required for Class II or III devices. Therefore, the "acceptance criteria" here primarily relate to matching or improving upon the predicate device's specifications and performance where relevant to safety, and proving adherence to general controls and applicable standards.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document explicitly states "SAME" for most elements, indicating direct equivalence to the predicate device, KaVo 625 (K760929). The primary "acceptance criteria" are implied to be at least matching the predicate, with improvements considered a benefit.
| Element of Comparison / Acceptance Criteria | Predicate Device (KaVo 625 Handpieces K760929) | MK-dent® HS 2012/2014 Reported Performance | Acceptance Status |
|---|---|---|---|
| Intended Use | General dentistry by trained professional | SAME (General dentistry by trained professional) | Met |
| Materials - Handpiece housing | Copper-tin bronze | SAME (Copper-tin bronze) | Met |
| Materials - Turbine housing | Nickel silver CDA alloy | SAME (Nickel silver CDA alloy) | Met |
| Materials - Turbine housing cap | Stainless steel | SAME (Stainless steel) | Met |
| Plating | Chrome | SAME (Chrome) | Met |
| Energy Source | Air pressure, 30-32 psi | SAME (Air pressure, 30-32 psi) | Met |
| Sterilization Method | Steam autoclave or ETO | Steam autoclave | Acceptable (narrowed, but still common and validated) |
| Bur Retention Strength | 6 lbs | 8 lbs | Met (Improved) |
| Weight | (Not specified, but implied to be heavier) | 2 oz (Reduction) | Met (Improved) |
| Knurling on handle | (Not specified, but implied to be harder to clean) | Softened (Improved cleanability and tactile sense) | Met (Improved) |
| Biocompatibility | Conforms to materials used | Confirmed by use of same specification materials | Met |
| Conformity to ISO standards | Conforms to applicable ISO standards | Conforms to applicable ISO standards | Met |
| Ability to repeatedly adequately sterilize | Demonstrated | Confirmed by validation protocol | Met |
2. Sample size used for the test set and the data provenance
The document does not detail a specific "test set" in the sense of a clinical trial or a formal performance evaluation with a defined sample size of devices or patients. The demonstration of equivalence relies primarily on:
- Design comparison: Stating that the device "shares virtually all specifications and design characteristics" with the predicate.
- Bench testing (for bur retention): The increase in bur retention strength from 6 lbs to 8 lbs implies a lab-based, bench test was performed. No sample size is given for this or the sterilization validation.
- Material comparison: Directly stating "SAME" for materials suggests a comparison of material specifications rather than a new "test set" of devices undergoing evaluation.
Data Provenance: Not explicitly stated for any tests mentioned. Given the manufacturer (MK-dent®) is German (implied by the address of Dr. Martina Günderoth in Lübeck, GERMANY), any internal testing would likely be performed in Germany. The FDA reviewed the submission in the United States.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable in the context of this 510(k) submission. This type of device (Class I dental handpiece) does not typically require expert-adjudicated test sets for performance or safety. The "ground truth" for design equivalence and material specifications would be based on engineering drawings, material safety data, and objective physical measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of a human expert test set requiring adjudication in this 510(k).
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. This is a mechanical dental handpiece, not an AI-powered diagnostic device. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this submission is primarily based on:
- Predicate device specifications: The established performance and material specifications of the legally marketed KaVo 625 Handpiece (K760929).
- Engineering specifications and material science: For details like material composition, dimensions, and bur retention force.
- Validation protocols: For confirming sterilization efficacy according to established standards.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for a mechanical device like this.
9. How the ground truth for the training set was established
Not applicable.
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Image /page/0/Picture/2 description: The image shows a sequence of characters and numbers written in black ink on a white background. The sequence starts with the letter 'K', followed by the numbers '021250'. The handwriting appears somewhat stylized, with rounded shapes for the numbers and a distinct form for the letter 'K'.
4. Summary of Safety and Effectiveness
OCT 2 4 2002 4.1 ldentification of Device
MK-dent® Push Button Highspeed Handpiece, 4 Holes, Trade Name: Models: HS 2012 (Standard Head) and HS 2014 (Small Head)
Handpiece, air-powered, dental Common/Usual Name:
Classification Name: Dental handpiece
Device Class: Class I
76 EFB Product Code
4.2 Equivalent Device
Equivalent leqally marketed device: KaVo 625 Dental Handpiece (K760929)
4.3 Indications for Use
The device is an air-powered dental handpiece for use by a trained professional in general dentistry.
Description of Device 4.4
The MK-dent® HS 2012/2014 shares virtually all specifications and design characteristics of the predicate devices. This was done intentionally by the designers and engineers. The only major design change refers to the strength of the auto chuck mechanism. By increasing the spring strength, we have created a more reliable version compared to KaVo 625. By increasing the bur retention strength from 6 lbs (as with the predicate device) to 8 lbs. (MK-dent® HS 2012/2014) we have been able to vastly reduce the odds of a bur prematurely ejecting from the handpiece. A few minor changes to the predicate device which do not affect the performance but we feel make the handpiece convenient to use are as follows: Reduction in the weight of the handpiece to 2 oz.. This reduces operator hand fatigue. Softening the knurling on the handle. This allows dirt, blood and salvia to be more easily removed from the body shell of the handpiece, thus allowing better conformity to sterilization procedures. It also provides better tactile sense to the operator while wearing gloves.
4.5 Safety and Effectiveness, comparison to predicate device
| Element of Comparison | - KaVo 625 Handpieces (K760929) | MK-dent® HS 2012/2014 |
|---|---|---|
| Intended Use | General dentistry by trained professional | SAME |
| Materials: | - Handpiece housing: - Copper-tin bronze- Turbine housing: - Nickel silver CDA alloy- Turbine housing cap: - Stainless steel | SAME |
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| - Plating | - Chrome | |
|---|---|---|
| Energy Source | Air pressure, 30-32 psi | SAME |
| Sterilization | Steam autoclave or ETO | Steam autoclave |
4.6 Conclusion
In all respects, the MK-dent® HS 2012/2014 is substantially equivalent to one or more air-powered 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 devices has been confirmed by validation protocol.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings and head. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850
Dr. Martina Günderoth C.R.C. Partnerschaftsgesellschaft Katharinenstr. 5 23554 Lübeck, GERMANY
Re: K021250
Trade/Device Name: MK-dent® HS 2012/2014 Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EBF Dated: August 8, 2002 Received: August 19, 2002
Dear Dr. Günderoth:
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.
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 - Dr. Günderoth
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 and additionally 21 CFR Part 809.10 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ulatowski 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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510(k) Notification: MK-Dent® HS 2012 Dental Handpiece
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Indications for Use 3.
510(k) Number ________________________________________________________________________________________________________________________________________________________________
Device Name: MK-dent® HS 2012/2014
Indications for Use: The device is an air-powered dental handpiece for use by a trained professional in general dentistry.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_
OR
Over the Counter Use (Per 21 CFR 801.109)
Espitz DDS for Dr. Susan Kummer
(Division Sign-Off) (Division Sign-On)"
Division of Anesthesiology, General Hospital, Division of Ansolnoomsental Devices
510(k) Number: K021250
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.