(104 days)
No
The description details a mechanical and software-controlled system for cleaning and lubricating dental handpieces with user-selectable settings, but there is no mention of AI or ML capabilities for decision-making, pattern recognition, or adaptive behavior.
No
This device is intended for cleaning and lubrication of dental handpieces, not for direct medical treatment or diagnosis of a patient.
No
The device is described as a "Handpiece Maintenance System" intended for "cleaning and lubrication of dental Handpieces." Its function is to
maintain equipment, not to diagnose medical conditions in patients.
No
The device description explicitly lists numerous hardware components, including a main case, PCBA boards, power supply, adapters module, LCM module, oil supply module, solenoid valve, rotation motor module, etc. This indicates it is a physical device with integrated software for control, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "cleaning and lubrication of dental Handpieces including air turbines, air motors and air driven scalers prior to sterilization." This describes a process for maintaining dental equipment, not for performing tests on biological samples to diagnose or monitor a medical condition.
- Device Description: The description details a system for dispensing cleaning and lubricating fluids into dental handpieces. It focuses on mechanical processes and the application of a lubricant.
- Lack of IVD Characteristics: An IVD device is typically 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 human specimens in this way.
The device is a piece of dental equipment maintenance machinery.
N/A
Intended Use / Indications for Use
The Maxima XTEND Handpiece Maintenance System is intended for cleaning and lubrication of dental Handpieces including air turbines, air motors and air driven scalers prior to sterilization.
Product codes (comma separated list FDA assigned to the subject device)
EFB
Device Description
Maxima XTEND Handpiece Maintenance System is a complete automatic dispensing system for cleaning: lubrication and purging old oil for dental handpieces prior to sterilization cvcles.
User can use push button kev pad to select time for purqing lubricant into handpiece including 15 seconds, 20 seconds, and 30 seconds. In addition, there are 11 adjustable settings for the amount of lubricant into the handpiece; user can choose the amount of lubricant to purge into handpieces accordingly. The system can maintenance up to 3 handpieces at the same time, and an unique chuck care nozzle to lubricate chucks in dental turbines.
Service Maxima XTEND Handpiece maintenance system is capable to operate with aerosol lubricant can with or without compressed-air supply. Air pressure will deliver Lubricant directly through internal parts of handpieces and contra angles by the controlling of software to open and close magnetic valves. The system will purge all the excess lubricant. The provided linen pads and removable trays on front side and bottom of the system will absorb the excess liquid of lubricant.
Lubricant uses for the Maxima Handpiece Maintenance System is aerosol spray can "Maxima Handpiece Cleaner & Lubricant" has been previous cleared with 510(k) # K113674
The Maxima XTEND Handpiece Maintenance System contains following main components:
- Main case
- Rear case
- Front door module
- PCBA board
- Power supply
- Adapters module
- LCM Module
- Oil supply module
- Solenoid valve
- Rear components module
- Back plate cover
- Top cover
- Veneer (Bright Blue)
- Oil trav
- Rotation motor module
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
Dental back office
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)
Based on product testing results in attachment 3: there are no significant changes in performance of testing handpieces after 250 cycles of testing by using Maxima XTEND and STAMATIC 31 Handpiece Maintenance Unit. The performance of these handpieces including speed, torque bur extraction force and concentricity which do not change significantly compared from the beginning of the test to the end result of the performance testing. The lubrication performance of Maxima XTEND Handpiece Maintenance System on the testing handpieces is similar to lubrication performance of the STATMATIC 31 Handpiece Maintenance Unit on the testing handpieces. Therefore, Handpiece Headquarters believes the performance of Maxima XTEND Handpiece Maintenance System is as safe and effective as predicate device.
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.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, arranged in a cascading manner.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 17, 2015
Handpiece Headquarters Mr. Sonny Phung Product Engineer 620 S. Placentia Ave. Placentia, CA 92870
Re: K143183
Trade/Device Name: Maxima XTEND Handpiece Maintenance System Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: December 2, 2014 Received: December 3, 2014
Dear Mr. Phung:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Image /page/1/Picture/8 description: The image shows a signature with the name "Tina Kiang -S" written in black ink. The signature is stylized with a flourish to the left of the name. The name is written in a simple, legible font. The signature appears to be on a white background.
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K143183
Device Name: Maxima XTEND Handpiece Maintenance System
Indications for Use:
The Maxima XTEND Handpiece Maintenance System is intended for cleaning and lubrication of dental Handpieces including air turbines, air motors and air driven scalers prior to sterilization.
Prescription Use × AND/OR (Per 21 CFR 801 Subpart D) 801 Subpart C)
Over-The-Counter Use_
(Per 21 CFR
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
Image /page/3/Picture/0 description: The image contains the logo for Handpiece Headquarters, a Henry Schein company. The words "Handpiece Headquarters" are in a stylized font, with the "H" in "Handpiece" being significantly larger and red. Above the text is a thin, jagged line resembling a heartbeat monitor. Below the main text, in a smaller font, it reads "A Henry Schein Company," with the Henry Schein logo included.
510(K) SUMMARY:
Reference: 510(k) Traditional Premarket Notification for Maxima XTEND Handpiece Maintenance System.
- a- Submitted by: HANDPIECE HEADQUARTERS 620 S. Placentia Ave. Placentia, CA 92870 Tel. 714-579-0175 Fax. 714-579-0186
- b- Contact person: Sonny Phung Tel. 714-579-0175 ext.4871 Fax. 714-579-0186 Email: son.phung@handpieceheadquarters.com Or son.phung@henryschein.com
- c- Date summary prepared: 12-02-2014
- d- Device Name:
Trade or Proprietary Name: Maxima XTEND Handpiece Maintenance System
Common Name: Dental Handpiece and accessories (Lubricant)
Classification Name: Dental Handpiece and accessories
Classification number: (21CFR 872.4200)
Class: I
Product Code: EFB
e- Substantial Equivalency is claimed against the following device:
STATMATIC 31 Handpiece Maintenance Unit by SciCan LTD. 510(k) # K073319
4
f- Description of the device:
Maxima XTEND Handpiece Maintenance System is a complete automatic dispensing system for cleaning: lubrication and purging old oil for dental handpieces prior to sterilization cvcles.
User can use push button kev pad to select time for purqing lubricant into handpiece including 15 seconds, 20 seconds, and 30 seconds. In addition, there are 11 adjustable settings for the amount of lubricant into the handpiece; user can choose the amount of lubricant to purge into handpieces accordingly. The system can maintenance up to 3 handpieces at the same time, and an unique chuck care nozzle to lubricate chucks in dental turbines.
Service Maxima XTEND Handpiece maintenance system is capable to operate with aerosol lubricant can with or without compressed-air supply. Air pressure will deliver Lubricant directly through internal parts of handpieces and contra angles by the controlling of software to open and close magnetic valves. The system will purge all the excess lubricant. The provided linen pads and removable trays on front side and bottom of the system will absorb the excess liquid of lubricant.
Lubricant uses for the Maxima Handpiece Maintenance System is aerosol spray can "Maxima Handpiece Cleaner & Lubricant" has been previous cleared with 510(k) # K113674
The Maxima XTEND Handpiece Maintenance System contains following main components:
- Main case 1
- വ Rear case
- Front door module ന
- 4 PCBA board
- 5 Power supply
- 6 Adapters module
- 7 LCM Module
- 8 Oil supply module
- ത Solenoid valve
- 10 Rear components module
- 11 Back plate cover
- 12 Top cover
- 13 Veneer (Bright Blue)
- 14 Oil trav
- 15 Rotation motor module
Image /page/4/Picture/25 description: The image shows a TT BIO machine with a white and blue color scheme. The machine has a door with an oval-shaped window in the center. The top of the machine has a blue panel with several buttons and a small display screen. The machine also has the TT BIO logo on the front.
g- Statement of Intended Use:
The Maxima XTEND Handpiece Maintenance System is intended for cleaning and lubricating of dental handpieces including air turbines, air motors and air driven scalers
5
prior to sterilization.
| 1-comparsion table: | ||
|---|---|---|
| FEATURES | MAXIMA XTEND HANDPICE | |
| MAINTENANCE SYSTEM | SCICAN STATMATIC | |
| (K073319) | ||
| Number of | ||
| connections | 4 | 4 |
| Build in chuck | ||
| adaptor | yes | Yes |
| Cycle times to | ||
| lubricate | ||
| handpiece | 15,20,25 seconds | |
| programmable | 15 Seconds | |
| Lubricant | ||
| change indicator | yes | Yes |
| Lubricant | ||
| containment | Maxima Handpiece cleaner& | |
| lubricant- Aerosol can- 510(k) |
K113674 | STATMATIC SPRAY
Aerosol can |
| Compress air | 58-87 psi. | 58-87 psi. |
| Air consumption | 40 NL/min | 40 NL/min |
| Dimensions | 295x385x295 mm
(11.6 x 15.15 x 11.6 in.) | 285x190x400 mm
(11.2 x 7.5 x 15.8 in.) |
| Weight | 9.0 Kg (19.8 Lbs.) | 8.6 Kg (18.96 Lbs.) |
| Warranty | 5 years | 10 Years |
H-comparison of technological characteristics:
2-Comparison of performance testing:
Based on product testing results in attachment 3: there are no significant changes in performance of testing handpieces after 250 cycles of testing by using Maxima XTEND and STAMATIC 31 Handpiece Maintenance Unit. The performance of these handpieces including speed, torque bur extraction force and concentricity which do not change significantly compared from the beginning of the test to the end result of the performance testing. The lubrication performance of Maxima XTEND Handpiece Maintenance System on the testing handpieces is similar to lubrication performance of the STATMATIC 31 Handpiece Maintenance Unit on the testing handpieces. Therefore, Handpiece Headquarters believes the performance of Maxima XTEND Handpiece Maintenance System is as safe and effective as predicate device.
i- Safety and effectiveness of the device:
Maxima XTEND Handpiece Maintenance System is as safety and effectiveness as the predicate device as cited above.
i- Biocompatibility
6
Maxima XTEND Handpiece Maintenance System is used in Dental back office, there is no patient contact with this device. There is no biocompability study for this device.
The Lubricant used for this device is the "Maxima Handpiece Cleaner & Lubricant" has been previous cleared under 510(k) # K113674. The chemical components used for this lubricant have already been incorporated in legally marketed device and have a demonstrated history of biocompatibility.
k- Conclusion:
The design and operation of this product has a similar intend of use, similar principles of operation, and similar technological characteristics as previous cleared devices: STAMATIC 31 Handpiece Maintenance Unit 510(k) # K073319.
In addition, similar design characteristic features such as number of handbiece coupling connections, connection to pressurized air supply, similar individual cycles time per instrument, similar push button operation, similar corrosion resistant material to build the machine, and an addition built in maintenance chuck-nozzle for cleaning and maintenance of dental turbine chucks.
Handpiece Headquarters believes that this Maxima XTEND Handpiece Maintenance System is substantially equivalent to the claimed predicate device.