(77 days)
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Not Found
No
The summary describes a simple battery-powered motor handpiece for dental work and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device is described as a low-speed motor handpiece for general dental works, which are procedures rather than therapeutic treatments. It does not appear to treat or prevent a disease or condition.
No
Explanation: The device is described as a motor handpiece for "light general dental works where low speed and low torque is required," which indicates a therapeutic or procedural rather than diagnostic function.
No
The device description explicitly states it is a "small battery-powered device, light-weight, low speed motor handpiece," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is a "small battery-powered device, light-weight, low speed motor handpiece, for use in light general dental works". This describes a tool used directly on a patient for a physical procedure (dental work), not a device used to examine specimens in vitro (outside the body) to diagnose or monitor a condition.
- Device Description: The description reinforces the intended use as a motor handpiece for dental work.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any diagnostic purpose.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a physical tool for performing dental procedures.
N/A
Intended Use / Indications for Use
The Power drive System is a small battery-powered device, light-weight, low speed motor handpiece, for use in light general dental works where low speed and low torque is required.
Product codes
EKX
Device Description
The Power drive System is a small battery-powered device, light-weight, low speed motor handpiece, for use in light general dental works where low speed and low torque is required.
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
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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)
Not Found
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
MediTeam
510(k) SUMMARY PER 21 CFR 807.92 1
This chapter contains commercial and confidential trade secret information and we respectfully request maximum protection provided by the law. Please refer to chapter INDICATIONS FOR USE, where you will find MediTeam Dental AB's official statement to be published on the World Wide Web.
Please note that the trade name "Carisolv" is mentioned in parts of the technical documentation (the Power drive is referred by MediTeam's subcontractor Schlumbohm OHG as "Carisolv Unit 3.01", see Appendix C, D, and E), and that a supplement to the PMA P000005 for the device "Carisolv Power drive" has been submitted in July 2001.
In accordance with 21 CFR 807.92, the following information constitutes the MediTeam Dental AB's summary for the Power drive.
1.1 Submitter
| Submitter's Name: | MediTeam Dental AB (publ) |
|---|---|
| Address: | Göteborgsvägen 74 |
| S-433 63 Sävedalen | |
| Sweden | |
| Contact Person: | Thomas Stjernkvist, M.Sc. |
| Vice President Quality Assurance | |
| Direct dial: | +46-31-336 91 03 |
| Fax Number: | +46-31-336 91 91 |
| E.mail: | thomas.stjernkvist@mediteam.com |
1.2 Date
510(k) Summary has been prepared on August 30th, 2001.
1.3 Reason for 510(k) submission
It is intended to put this device into commercial distribution for the first time in the US.
1.4 Trade Name
Power drive
1.5 Classification Name
Dental Handpiece and Accessories (21 CFR 872.4200)
1.6 Classification
The device is a general control of class I according to 21 CFR 872.4200 Product Code: EKX
1
Image /page/1/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized symbol. The symbol consists of three abstract, wavy lines that resemble a stylized human figure or a flame. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 0 2001
Mr. Thomas Stjernkvist Vice President Quality Assurance MediTeam AB Goteborgsvagen 74, Savedalen, SWEDEN
Re: K012944
Trade/Device Name: Power Drive Regulation Number: 872.4200 Regulation Name: Dental Headpiece and Accessories Regulatory Class: I Product Code: EKX Dated: August 30, 2001 Received: September 14, 2001
Dear Mr. Stjernkvist:
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
2
Page 2 - Mr. Stjernkvist
of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I ederal statutes and regisements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice allo listing (21 CFR Pur 007), labeling (21 CFR Part 820); and if requirents as set forth in the quality sized in 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 This letter will anow you to ochinians of substantial equivalence of your device to 910(x) promation notificate 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 IT you desire specific da rise 10. Jour in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and Office of Colliphance at e. 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 notheation (21 OF ICT of the Division of Small Manufacturers, International and the Act may of obtained 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
Timothy Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
3
MediTeam
NOV 2 0 2001
MediTeam Dental AB
INDICATIONS FOR USE
K012944 510(k) Number_
Device Name: Power drive
Indications for Use:
The Power drive System is a small battery-powered device, light-weight, low speed The Fower urre Bystein is a small on on to 450 rpm with a maximum torque of orconto motor handprover, for use in light general dental works where low speed and low torque is required.
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use ✓
| (Per 21 CFR 801.109) | OR | Over the Counter Use |
|---|---|---|
| -------------------------------------------------------------------------------------------- | ---- | ----------------------------------------------------------------------- |
Susan Russo
| Division Sign-Off | |
|---|---|
| Division of Dental, Infection Control, | |
| General Hospital Devices | |
| Number | 1812541 |