(2 days)
Not Found
No
The description focuses on the mechanical design and materials of a dental turbine and burs, with no mention of AI or ML.
No.
A therapeutic device is one that treats a disease or condition. This device is used for drilling and preparation, which are steps in a restorative procedure, not a treatment itself.
No
The device is described as a high-speed air-powered turbine used for drilling and preparation of dental cavities, which is a therapeutic rather than a diagnostic function.
No
The device description clearly details a physical, air-powered turbine and associated cutting instruments made of stainless steel and other materials, which are hardware components. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for drilling and preparation of dental cavities for restoration, such as fillings." This is a mechanical procedure performed directly on the patient's body (intraorally).
- Device Description: The device is a high-speed air-powered turbine designed to be installed in dental handpieces for cutting and preparing tooth structure. This is a surgical/dental tool.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The device is clearly a dental instrument used for a physical procedure within the mouth, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The ProDrive Replacement Turbine is intended for use by authorized persons in the practice of dentistry. The intended use of the ProDrive Replacement Turbine is identical to that of the Predicate Device.
To be used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings.
Product codes (comma separated list FDA assigned to the subject device)
EFB
Device Description
The ProDrive Replacement Turbine is a high-speed air-powered turbine designed to be installed in existing, legally marketed dental handpieces.
The ProDrive Replacement Turbine is appropriate for use with ProDrive carbide and diamond cutting instruments. A push-button spindle mechanism is used to grip the shanks of the cutting instruments. The unique geometry of the bur shank and turbine spindle securely locks the bur in the turbine eliminating the slipping that can occur over time with traditional burs and turbines. In addition to improved performance and durability, the secure locking mechanism enhances the safety of the ProDrive Replacement Turbine by reducing the risk of accidental disengagement of burs from the handpiece during operation.
When fully seated, the length that the ProDrive bur extends from the handpiece is the same as that of the standard bur/turbine assembly. In addition, the ProDrive system incorporates the ability to index the bur to a second, extended, position effectively improving on the visibility angle and the utility of the handpiece without adversely affecting its performance.
Because of the unique geometry of the ProDrive Replacement Turbine it is appropriate for use only in combination with ProDrive carbide and diamond cutting instruments. Standard round-shank burs will not fit into the ProDrive chuck, preventing their unintended use. ProDrive burs, however, will fit in traditional friction-grip chucks and will meet appropriate performance requirements when used in this way.
With the exception of the unique drive-lock spindle, the ProDrive Replacement Turbine consists of commercially available replacement parts currently used to refurbish dental handpieces in the United States. The spindle is composed entirely of stainless steel. The predicate device spindle is also manufactured from stainless steel. Therefore, the products are considered to be identical in materials used in their manufacture.
ProDrive burs are composed of tungsten vanadium stainless steel, coated with carbide or diamond cutting surfaces. The ProDrive burs are machined for ProDrive Systems Inc. by the bur manufacturer to the unique shank geometry required by the ProDrive drive-lock mechanism. In all other respects the burs are identical to commercially available burs currently distributed in the United States. The use of stainless steel in the manufacture of ProDrive spindles and burs ensures biocompatibility and resistance to corrosion.
The ProDrive Replacement Turbine meets or exceeds all of the applicable performances standards outlined in ISO 7785-1:1997(E). Extensive testing indicates that after 250 sterilization cycles the ProDrive Replacement Turbine continues to meet all performance requirements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Identical to predicate device
Indicated Patient Age Range
Not Found
Intended User / Care Setting
authorized persons in the practice of dentistry / intraorally
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)
The ProDrive Replacement Turbine combined with ProDrive burs conform to the ISO 7785-1:1997(E) standard and the FDA Guidance Document on Dental Handpieces, which include testing and performance limits on the following characteristics:
- Extraction force
- Resistance to corrosion
- Torque
- Noise level
- Eccentricity Speed
- Air pressure Sterility validation
- Stall torque
- Reprocessing
The performance testing of the ProDrive Replacement Turbine indicates that it functions as well as or better than the predicate device in all aspects examined. Therefore, we conclude that the ProDrive Replacement Turbine is both safe and effective for its intended use.
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
Image /page/0/Picture/0 description: The image shows the logo for "PRODRIVE SYSTEMS". The logo is in black and white, with the word "PRODRIVE" in large, bold letters. Below the word "PRODRIVE" is the word "SYSTEMS" in smaller letters. The letter "O" in "PRODRIVE" is replaced with a circle.
K06 2219
510(k) SUMMARY
ProDrive Replacement Turbine ProDrive Systems Inc.
AUG - 4 2006
Owned by:
ProDrive Systems Inc. 812 Commerce Drive Ogdensburg, NY 13669 USA
Contact Person:
Clive Hooton, Vice President Quality ProDrive Systems Inc. 812 Commerce Drive Ogdensburg, NY 13669 USA
Date of Summary:
June 28, 2006
Device Name:
ProDrive Replacement Turbine Proprietary Name: Common Name: turbine assembly for dental handpiece Classification Name: Handpiece, Air-powered, Dental Product Code: EFB ("Dental handpiece and accessories", 21CFR 872.4200)
Predicate Device:
Proprietary Name: 430 Series High Speed handpeice 510(k) Number: K960719 Product Code: EFA*
- Note that this handpiece is incorrectly identified in the CDRH database as EFA (handpiece, belt and/or gear driven, dental). It is, in fact, an air-powered handpiece (EFB), as is the device presented in this submission.
5
1
Image /page/1/Picture/0 description: The image shows the logo for "PRODRIVE SYSTEMS". The word "PRODRIVE" is in large, bold, sans-serif font, with a circle in place of the letter "O". Below "PRODRIVE" is the word "SYSTEMS" in a smaller, sans-serif font.
Description of Device:
The ProDrive Replacement Turbine is a high-speed air-powered turbine designed to be installed in existing, legally marketed dental handpieces.
The ProDrive Replacement Turbine is appropriate for use with ProDrive carbide and diamond cutting instruments. A push-button spindle mechanism is used to grip the shanks of the cutting instruments. The unique geometry of the bur shank and turbine spindle securely locks the bur in the turbine eliminating the slipping that can occur over time with traditional burs and turbines. In addition to improved performance and durability, the secure locking mechanism enhances the safety of the ProDrive Replacement Turbine by reducing the risk of accidental disengagement of burs from the handpiece during operation.
When fully seated, the length that the ProDrive bur extends from the handpiece is the same as that of the standard bur/turbine assembly. In addition, the ProDrive system incorporates the ability to index the bur to a second, extended, position effectively improving on the visibility angle and the utility of the handpiece without adversely affecting its performance.
Because of the unique geometry of the ProDrive Replacement Turbine it is appropriate for use only in combination with ProDrive carbide and diamond cutting instruments. Standard round-shank burs will not fit into the ProDrive chuck, preventing their unintended use. ProDrive burs, however, will fit in traditional friction-grip chucks and will meet appropriate performance requirements when used in this way.
With the exception of the unique drive-lock spindle, the ProDrive Replacement Turbine consists of commercially available replacement parts currently used to refurbish dental handpieces in the United States. The spindle is composed entirely of stainless steel. The predicate device spindle is also manufactured from stainless steel. Therefore, the products are considered to be identical in materials used in their manufacture.
ProDrive burs are composed of tungsten vanadium stainless steel, coated with carbide or diamond cutting surfaces. The ProDrive burs are machined for ProDrive Systems Inc. by the bur manufacturer to the unique shank geometry required by the ProDrive drive-lock mechanism. In all other respects the burs are identical to commercially available burs currently distributed in the
2
Image /page/2/Picture/0 description: The image shows the logo for "PRODRIVE SYSTEMS". The word "PRODRIVE" is written in all capital letters, with a circle in place of the letter "O". The word "SYSTEMS" is written in smaller capital letters below the word "PRODRIVE".
United States. The use of stainless steel in the manufacture of ProDrive spindles and burs ensures biocompatibility and resistance to corrosion.
The ProDrive Replacement Turbine meets or exceeds all of the applicable performances standards outlined in ISO 7785-1:1997(E). Extensive testing indicates that after 250 sterilization cycles the ProDrive Replacement Turbine continues to meet all performance requirements.
Intended Use of Device:
The ProDrive Replacement Turbine is intended for use by authorized persons in the practice of dentistry. The intended use of the ProDrive Replacement Turbine is identical to that of the Predicate Device.
Comparison of Technological Characteristics to Predicate Device:
The following table compares the features of the ProDrive Replacement Turbine to the Predicate Device:
| TECHNOLOGICAL CHARACTERISTIC | COMPARISON TO PREDICATE |
|---|---|
| Intended use | Identical |
| Indications for use | Identical |
| Target population | Identical |
| Anatomical sites | Identical |
| Where used | Identical |
| Energy used and/or delivered | Similar |
| Human factors | Similar |
| Design | Similar |
| Performance | Similar |
| Standards met | Similar |
| Materials | Identical |
| Biocompatibility | Identical |
| Compatibility with environment and other devices | Similar |
| Sterility | Similar |
| Electrical safety | Identical |
| Mechanical safety | Similar |
| Chemical Safety | Identical |
| Thermal safety | Similar |
| Radiation safety | Identical |
Table 1: Substantial Equivalence Table
3
Image /page/3/Picture/0 description: The image shows the logo for "PRODRIVE SYSTEMS". The word "PRODRIVE" is in large, bold, sans-serif font, with a circle replacing the letter "O". Below "PRODRIVE" is the word "SYSTEMS" in a smaller, lighter font.
Conclusions Drawn from Technical Comparison:
The ProDrive Replacement Turbine is essentially the same as the predicate device in terms of its intended use, operating principles and materials.
The ProDrive Replacement Turbine combined with ProDrive burs conform to the ISO 7785-1:1997(E) standard and the FDA Guidance Document on Dental Handpieces, which include testing and performance limits on the following characteristics:
●
- Extraction force .
- . Resistance to corrosion
- Torque .
.
♥
- Noise level .
- Eccentricity Speed
- Air pressure Sterility validation .
- Stall torque
- Reprocessing .
The performance testing of the ProDrive Replacement Turbine indicates that it functions as well as or better than the predicate device in all aspects examined. Therefore, we conclude that the ProDrive Replacement Turbine is both safe and effective for its intended use.
8
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ProDrive Systems, Incorporated C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313
AUG - 4 2006
Re: K062219
Trade/Device Name: ProDrive Systems Replacement Turbine Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: July 31, 2006 Received: August 2, 2006
Dear Mr. Job:
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 Amendie comments, 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 approvisions 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 If your device is classes to such additional controls. Existing major regulations affecting (1 wr 1), it a 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.
5
Page 2 - Mr. Job
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. 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), 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Swer Quare
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
6
Indications for Use
510(k) Number (if known): Not yet assigned
The ProDrive Replacement Turbine Device Name:
To be used intraorally by trained dental professionals for Indications For Use: drilling and preparation of dental cavities for restoration, such as fillings.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Super Quary
on Sign-Cif) ്ന of Anesthesiology, General Hospital, Jon Control, Dental Devices
. (1) Number:
Page 1 of ____________________________________________________________________________________________________________________________________________________________________