(188 days)
Not Found
No
The description focuses on mechanical improvements and design changes to a dental handpiece, with no mention of AI or ML technology.
No
The device is described as an air-powered dental handpiece for use in general dentistry, which is used for mechanical procedures (like drilling) and not directly for therapy.
No
The device, an air-powered dental handpiece, is used in general dentistry for procedures, not for diagnosing medical conditions. Its description focuses on mechanical improvements and user convenience, not on detecting or identifying diseases or conditions.
No
The device description clearly describes a physical, air-powered dental handpiece with mechanical components (auto chuck mechanism, spring, bur retention). It discusses physical characteristics like weight, knurling, and sterilization, all indicative of a 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 for use by a trained professional in general dentistry." This describes a tool used directly on a patient for dental procedures, not a device used to examine specimens in vitro (outside the body).
- Device Description: The description focuses on the mechanical aspects of the handpiece, such as the auto chuck mechanism, bur retention strength, weight, and handle design. These are all related to its function as a surgical/procedural tool.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process that would be performed in vitro to diagnose a condition.
IVD devices are specifically designed to examine specimens obtained from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This dental handpiece does not fit that description.
N/A
Intended Use / Indications for Use
The device is an air-powered dental handpiece for use by a trained professional in general dentistry.
Product codes (comma separated list FDA assigned to the subject device)
EFB
Device Description
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.
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
§ 872.3690 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.
0
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 |
1
| - 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.
2
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.
3
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
4
510(k) Notification: MK-Dent® HS 2012 Dental Handpiece
Image /page/4/Picture/1 description: The image shows a series of handwritten characters and numbers, seemingly arranged in a sequence. The sequence starts with the letter 'K', followed by the numbers '021250'. In the bottom right corner of the image, the text '7 of 35' is visible, suggesting that this image is part of a larger document or series of images. The handwriting appears somewhat rough and uneven, giving the image a casual, handwritten feel.
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