(30 days)
Not Found
No
The document describes a mechanical dental handpiece and does not mention any AI or ML components or functionalities.
No.
The device is a low-speed dental motor used for various dental procedures, such as grinding, polishing, and cavity preparation, which are considered mechanical operations rather than therapeutic interventions aimed at curing or treating diseases or medical conditions.
No
The device, a low-speed dental handpiece, is described for use in performing various dental procedures such as grinding, polishing, cavity preparation, and implant setting. These are all procedural/therapeutic uses, not diagnostic.
No
The device description clearly states it is an "air driven low speed dental motor" and "air driven handpieces," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "dental non-surgical operatory and laboratory procedures" and lists examples like grinding, polishing, cavity preparation, etc. These are all procedures performed directly on or in the patient's mouth or on dental prosthetics, not on samples taken from the body for diagnostic purposes.
- Device Description: The description reinforces its use in "non-surgical dental laboratory and operatory applications" and its coupling with attachments for performing procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health condition.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This dental handpiece does not fit that description.
N/A
Intended Use / Indications for Use
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 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 .
Product codes (comma separated list FDA assigned to the subject device)
EFB
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.
The handpieces utilize materials commonly krown for their ability to withstand many exposures to common cleaning and disinfecting agents and steam sterilization.
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
licensed practitioners / dental laboratory and operatory
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
§ 872.4200 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
Ko7000/
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
· · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·
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 and
| Lynx Classic 5K Classic Air Motor | K940261 |
|---|---|
| Lynx TM5 - 5K | K940261 |
| Lynx TM20 - 20K Torquemaster | K940261 |
1
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.
2
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.
3
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
4
MTI PRECISION PRODUCTS
175 Oberlin Avenue
Lakewood, New Jersey 08701
| Page 1 of 1 | |
|---|---|
| -- | ------------- |
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