(30 days)
The Lube Free Low Speed Handpiece line comprises a family of air driven low speed dental motors, FDA classification code EFB, for use in dental non-surgical operatory and laboratory procedures by licensed practitioners. The dental motors are known as: Master Classic 5K Low Speed Handpiece Master Classic 20K Low Speed Handpiece Master TM5 5K Low Speed Handpiece Master TM20 20K Low Speed Handpiece The following are examples for which the motors can be utilized. Note that these are just examples and not limitations of the procedures for which the handpieces can be used. - . Grinding and trimming on dentures and bridge work. - Polishing and finishing of natural dentition . - Endodontio abcess procedures . - Cavity preparation. t - Crown and cap preparation . - Post and pin setting . - Implant setting .
The Master line of air driven handpieces are intended for use in a variety of non-surgical dental laboratory and operatory applications. They are typically coupled with a selection of attachments and angle heads to provide the licensed practitioner with the correct range of torque and speed to perform the desired procedure.
This 510(k) submission document pertains to a Class I medical device, the "Master line of air driven handpieces" for dental applications. Class I devices are subject to general controls and typically do not require extensive clinical studies or robust acceptance criteria demonstrations like those needed for higher-risk devices. Therefore, the information you've requested regarding detailed acceptance criteria and a study proving performance against them is not present in this type of submission for a Class I device.
Instead, the submission focuses on demonstrating substantial equivalence to a legally marketed predicate device. This usually involves showing that the new device has the same intended use, technological characteristics, and safety and effectiveness as the predicate.
Here's an analysis based on the provided document, addressing your questions where applicable and explaining why certain information is absent:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. For Class I devices like dental handpieces, the "acceptance criteria" are generally tied to demonstrating equivalence in functionality, materials, and sterilization to existing predicate devices, rather than specific quantitative performance metrics tested against pre-defined thresholds. The submission asserts that the device utilizes "materials commonly known for their ability to withstand many exposures to common cleaning and disinfecting agents and steam sterilization," which implies meeting common industry standards for device durability and reusability, but no specific performance data or acceptance targets are listed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. As explained above, for Class I devices seeking 510(k) clearance through substantial equivalence, a formal "test set" in the context of a robust performance study (like for AI/diagnostic devices) is generally not required or performed for a device like a dental handpiece. The evaluation is often based on engineering specifications, material properties, and comparison to the predicate device.
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)
This information is not applicable/not provided. There is no "ground truth" establishment as would be required for a diagnostic device or an AI algorithm. The device's function is mechanical, and its intended uses are well-established dental procedures.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. There is no "test set" and no "adjudication" in the context of expert review for this type of device submission.
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
This information is not applicable/not provided. This device is a mechanical dental handpiece, not an AI or diagnostic tool. Therefore, an MRMC study is entirely irrelevant to its submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/not provided. As a mechanical device for dental procedures, the concept of "ground truth" as used in diagnostic or AI device evaluations does not apply. The device's effectiveness relies on its ability to perform its mechanical functions (e.g., rotation, torque, speed) reliably and safely, analogous to the predicate device.
8. The sample size for the training set
This information is not applicable/not provided. There is no AI component or "training set" for a mechanical dental handpiece.
9. How the ground truth for the training set was established
This information is not applicable/not provided. As there is no AI component or "training set," there's no ground truth to establish for it.
Summary of what the document does provide:
- Predicate Devices: The document clearly identifies the predicate device as "Lynx Classic 5K / Classic Air Motor," "Lynx TM5 - 5K," and "Lynx TM20 - 20K" (K940261).
- Intended Use & Indications for Use: The document clearly states the intended use for "dental laboratory and operatory non-surgical procedures by licensed practitioners" and provides examples like grinding, polishing, cavity preparation, etc.
- Device Description: It describes the device as "air driven handpieces" coupled with attachments for various dental procedures, emphasizing the use of materials "commonly known for their ability to withstand many exposures to common cleaning and disinfecting agents and steam sterilization."
- Substantial Equivalence: The primary objective of this 510(k) submission is to demonstrate substantial equivalence to the predicate devices, thereby ensuring the new device is as safe and effective as devices already on the market. The FDA's letter explicitly states, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices."
In conclusion, for a Class I mechanical device like a dental handpiece, the regulatory pathway focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive performance studies with detailed acceptance criteria and ground truth establishment typically found for novel, higher-risk, or AI-driven devices.
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Page 1 of 2
Joseph Deluta
510(K) Submission
| PREPARED BY: | |
|---|---|
| Tod Brenner | |
| DATE: | 12/23/06 |
| DATE: | 12-23-06 |
|---|---|
| ------- | ---------- |
APPROVED BY:
TITLE: LUBE FREE LOW SPEED HANDIPIECE PRODUCT LINE
SECTION 5: 510(k) SUMMARY
FEB - 2 2007
The following submission has been prepared pursuant to requirements specified in 21CFR, Para 807.92
Contact Information:
Tod Brenner, Vice President, Engineering and Manufacturing MTI Dental Products 175 Oberlin Ave., North Lakewood, NJ. 08701 Phone: 732-905-7440 Fax: 732-905-7445
Date: October 25, 2006
Trade Names:
A
Master Classic 5K Low Speed Handpiece Master Classic 20K Low Speed Handpiece Master TM5 Low Speed Handpiece - -Master TM20 Low Speed Handpiece
Common Name:
Low Speed Air Driven Dental Handpiene
Classification Name:
Handpiece, Air-Powered (21 CFR 872.4200)
ునుండి విశ్రీ శాసన
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Classification Product Code: ------------------------------------EFB
Predicate Devices:
| A month and the county of the county of the county of the first of the first of the first of the first of the first of the first of the first of the first of the first andLynx Classic 5K Classic Air Motor | K940261 |
|---|---|
| Lynx TM5 - 5K | K940261 |
| Lynx TM20 - 20K Torquemaster | K940261 |
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Device Description:
The Master line of air driven handpieces are intended for use in a variety of non-surgical dental laboratory and operatory applications. They are typically coupled with a selection of attachments and angle heads to provide the licensed practitioner with the correct range of torque and speed to perform the desired procedure.
Intended Uses:
The Master product line of air motors will be used in dental laboratory and operatory nonsurgical procedures by licensed practitioners.
The following are examples for which the motors can be utilized. Note that these are just examples and not limitations of the procedures for which the handpieces can be used.
- Grinding and trimming on dentures and bridge work. .
- Polishing and finishing of natural dentition .
- Endodontic access procedures .
- . Cavity preparation.
- Crown and cap preparation .
- . Post and pin setting
- Implant setting .
The handpieces utilize materials commonly krown for their ability to withstand many exposures to common cleaning and disinfecting agents and steam sterilization.
Image /page/1/Picture/13 description: The image is a black and white photograph that appears to be of a landscape. The image is grainy and has a high contrast, which makes it difficult to discern specific details. There are some areas that appear to be darker, which could be trees or other vegetation. The image is likely taken from a distance, as the details are not very clear.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Tod H. Brenner Vice President MTI Precision Products 175 Oberlin Avenue North Lakewood, New Jersey 08701
Re: K070001
Trade/Device Name: Master Classic 5K Low Speed Handpiece Master Classic 20K Low Speed Handpiece Master TM5 5K Low Speed Handpiece Master TM20 20K Low Speed Handpiece ------------------------------------------------------------------------------------------------------------------------------------------------------Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: December 5, 2006 Received: January 3, 2007
FEB - 2 2007
Dear Mr. Brenner:
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 - Mr. Brenner
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. or the Fet of any vith 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,
Chiu Lin, Ph.D.
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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MTI PRECISION PRODUCTS
175 Oberlin Avenue
Lakewood, New Jersey 08701
| Page 1 of 1 | |
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| -- | ------------- |
510(K) Submission
| PREPARED BY: | Tod Brenner |
|---|---|
| DATE: | 12/23/06 |
| APPROVED BY: | Joseph Deluca |
|---|---|
| DATE: | 12-23-06 |
TITLE: LUBE FREE LOW SPEED HANDPIECE PRODUCT LINE# SECTION 4: STATEMENT OF INDICATIONS FOR USE
The Lube Free Low Speed Handpiece line comprises a family of air driven low speed dental motors, FDA classification code EFB, for use in dental non-surgical operatory and laboratory procedures by licensed practitioners. The dental motors are known as:
Master Classic 5KLow Speed Handpiece Master Classic 20K Low Speed Handpiece Master TM5 5K Low Speed Handpiece Master TM20 20K Low Speed Handpiece
The following are examples for which the motors can be utilized. Note that these are just examples and not limitations of the procedures for which the handpieces can be used.
- . Grinding and trimming on dentures and bridge work.
- Polishing and finishing of natural dentition .
- Endodontio abcess procedures .
- Cavity preparation. t
- Crown and cap preparation .
- Post and pin setting .
- Implant setting .
The handpieces utilize materials known for their ability to withstand many exposures to
common cleaning and disinfection and steam sterilization.
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K070001
§ 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.