(108 days)
No
The description focuses on mechanical and electrical components and adjustments, with no mention of AI or ML.
Yes
The device is used for periodontal pocket lavage, scaling, root planing, and removal of calculus and stains, all of which are therapeutic procedures aimed at treating dental and periodontal conditions.
No
Explanation: The device is an ultrasonic scaler used for cleaning and removing calculus from teeth, which is a treatment function, not a diagnostic one.
No
The device description clearly outlines hardware components such as a control unit, handpiece, handpiece cord, power knob, rotating knob for liquid flow, and connections for external water supply. It is a physical device with software controlling its functions, not a software-only device.
Based on the provided information, the PIEZON 150 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- PIEZON 150 Function: The PIEZON 150 is a dental device that uses ultrasonic vibrations and water to perform procedures directly on the patient's teeth and gums (scaling, root planning, calculus removal). It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly describes procedures performed in the mouth on the patient, not on samples in a lab.
Therefore, the PIEZON 150 falls under the category of a dental device used for treatment and cleaning, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PIEZON 150 is a device for delivering ultrasonic movement and water to a stainless steel tip which is used by a dentist or dental hygienist. The indications for use are:
- Periodontal pocket lavage with simultaneous ultrasonic tip movement.
- Scaling and root planing
- Removal of supra and subgingival calculus and stains from teeth.
Product codes
ELC
Device Description
The proposed PIEZON 150 ultrasonic scaler is a modification of the previously cleared miniPiezon (K953026). The working instrument for the scaling function is the handpiece, which is connected to the control unit via a handpiece cord and mounted in a holder on the side of the control unit.
The PIEZON 150 connects to an external water supply and delivers water via the connected handpiece. The power of ultrasonic vibrations is adjusted via a power knob on the top of the control unit. The flow rate of the irrigating liquid is adjusted via a rotating knob located on the side of the control unit.
The PIEZON 150 is supplied with two handpieces - the Piezon Handpiece LED (lightemitting diode) or the Piezon Handpiece. The Piezon Handpiece LED is identical to the Piezon Handpiece LED described in K093000 for the Piezon Master 700 ultrasonic scaler (K093000) and contains 6 LEDs in the body of the handpiece and a light guide that is positioned under the nozzle. The Piezon Handpiece is identical to the Piezon Handpiece LED, except that the Piezon Handpiece does not have LEDs or the light guide. All instruments compatible with the PIEZON 150 have been previously cleared (see 510(k) numbers referenced in Section 3).
The modifications made to the miniPiezon to produce the PIEZON 150 include:
- Shape and contours of the control unit redesigned to accommodate the finger-tip power control, improve aesthetics, facilitate cleaning, and enhance ergonomics
- Use of a potentiometer for power regulation via the power control knob to improve ultrasonic power control.
- One operating mode with a Standard power range (0-100% power) for scaling procedures and a Perio range (0-37.5% power) for periodontal procedures
- Supported handpieces (Piezon Handpiece (FT-215#) and Piezon Handpiece LED (FT-223#)
- Ultrasonic generator upgraded to EJ-110. the Light command, Motor/Solenoid valve command and Pedal command have been added.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Subgingival and supragingival
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentist or dental hygienist
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)
Non-clinical performance testing demonstrates that all design inputs for the PIEZON 150 were satisfied by the design outputs, that the device meets electrical safety and electromagnetic compatibility requirements, and functional and performance requirements. The similarities in intended use, operational characteristics, and functional technological characteristics between the proposed PIEZON 150 and the parent miniPiezon and predicate Piezon Master 700 lead to a conclusion of substantial equivalence between the proposed and predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K093000, K050710, K992504, K896749, K022328, K093000
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
§ 872.4850 Ultrasonic scaler.
(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.
0
NOV 2 2 2013
PIEZON 150 Special 510(k): Device Modification 510(k) Summary (per 21 CFR 807.92(c)) K132443
1. SUBMITTER/510(K) HOLDER
E.M.S. ELECTRO MEDICAL SYSTEMS S.A. Ch. de la Vuarpillière 31 CH - 1260 Nyon Switzerland
Contact Person: Suzanne Fassio-Hardy Telephone: 022 994 47 00
Date Prepared: October 24, 2013
2. DEVICE NAME
| Proprietary Name: | PIEZON 150 |
|---|---|
| Common/Usual Name: | Ultrasonic Scaler |
| Classification Name: | Ultrasonic Scaler (21 CFR 872.4850, Product Code ELC) |
3. PREDICATE DEVICES
The proposed PIEZON 150 is a modification of the E.M.S. ELECTRO MEDICAL SYSTEMS S.A., miniPiezon (K953026).
The Piezon Handpiece LED that is compatible with the proposed device was described in the 510(k) premarket notification for the Piezon Master 700 (K093000).
The instruments used with the PIEZON 150 were previously cleared by FDA:
- · E.M.S. ELECTRO MEDICAL SYSTEMS S.A., miniMaster Ultrasonic Scaler (K050710)
- · E.M.S. ELECTRO MEDICAL SYSTEMS S.A., EMS Kermit (K992504)
- · E.M.S. ELECTRO MEDICAL SYSTEMS S.A., miniPiezon (K953026)
- · E.M.S. ELECTRO MEDICAL SYSTEMS S.A., Piezon Master 400 (K896749)
- · E.M.S. ELECTRO MEDICAL SYSTEMS S.A., Piezon Master 600 (K022328)
- · E.M.S. ELECTRO MEDICAL SYSTEMS S.A., Piezon Master 700 (K093000)
1
4. DEVICE DESCRIPTION
The proposed PIEZON 150 ultrasonic scaler is a modification of the previously cleared miniPiezon (K953026). The working instrument for the scaling function is the handpiece, which is connected to the control unit via a handpiece cord and mounted in a holder on the side of the control unit.
The PIEZON 150 connects to an external water supply and delivers water via the connected handpiece. The power of ultrasonic vibrations is adjusted via a power knob on the top of the control unit. The flow rate of the irrigating liquid is adjusted via a rotating knob located on the side of the control unit.
The PIEZON 150 is supplied with two handpieces - the Piezon Handpiece LED (lightemitting diode) or the Piezon Handpiece. The Piezon Handpiece LED is identical to the Piezon Handpiece LED described in K093000 for the Piezon Master 700 ultrasonic scaler (K093000) and contains 6 LEDs in the body of the handpiece and a light guide that is positioned under the nozzle. The Piezon Handpiece is identical to the Piezon Handpiece LED, except that the Piezon Handpiece does not have LEDs or the light guide. All instruments compatible with the PIEZON 150 have been previously cleared (see 510(k) numbers referenced in Section 3).
The modifications made to the miniPiezon to produce the PIEZON 150 include:
- · Shape and contours of the control unit redesigned to accommodate the finger-tip power control, improve aesthetics, facilitate cleaning, and enhance ergonomics
- · Use of a potentiometer for power regulation via the power control knob to improve ultrasonic power control.
- · One operating mode with a Standard power range (0-100% power) for scaling procedures and a Perio range (0-37.5% power) for periodontal procedures
- · Supported handpieces (Piezon Handpiece (FT-215#) and Piezon Handpiece LED (FT-223#)
- · Ultrasonic generator upgraded to EJ-110. the Light command, Motor/Solenoid valve command and Pedal command have been added.
5. INTENDED USE
The PIEZON 150 is a device for delivering ultrasonic movement and water to a stainless steel tip which is used by a dentist or dental hygienist. The indications for use are:
- Periodontal pocket lavage with simultaneous ultrasonic tip movement .
- . Scaling and root planing
2
- . Removal of supra and subgingival calculus and stains from teeth
6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICES
The proposed PIEZON 150 is similar in design and materials to the parent miniPiezon. Both the proposed and parent devices are ultrasonic scalers consisting of a control unit housing an ultrasonic generator that produces piezo-electric vibrations to perform the scaling function. The working instrument for both the proposed and predicate devices is the handpiece, which is connected to a control unit via a handpiece cord. A scaling instrument specific to a particular scaling procedure is attached to the end of the handpiece. Both the proposed and predicate ultrasonic scalers connect to an external water supply and deliver water via the connected handpiece.
Differences between the proposed PIEZON 150 and the predicate miniPiezon and the Piezon Master 700 are limited to the compatible handpieces and the control unit modifications to improve ergonomics and ultrasonic power control described in Section 4. The similarities and differences between the proposed and parent devices are illustrated in the table at the end of this section.
7. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
Non-clinical performance testing demonstrates that all design inputs for the PIEZON 150 were satisfied by the design outputs, that the device meets electrical safety and electromagnetic compatibility requirements, and functional and performance requirements. The similarities in intended use, operational characteristics, and functional technological characteristics between the proposed PIEZON 150 and the parent miniPiezon and predicate Piezon Master 700 lead to a conclusion of substantial equivalence between the proposed and predicate devices.
8. SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
No clinical testing was conducted for this submission.
9. SUMMARY OF OTHER INFORMATION
No other information is available.
3
10. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS
The similarities in intended use, operational characteristics, and functional technological characteristics between the proposed PIEZON 150 and the parent miniPiezon and predicate Piezon Master 700 lead to a conclusion of substantial equivalence between the proposed and predicate devices. A side-by-side comparison of the predicate devices and the proposed device is provided in the table at the end of this section.
| Item for
Comparison | PIEZON 150
(FT-215#)
Piezon Handpiece
Proposed | PIEZON 150
(FT-223#)
Piezon Handpiece
LED
Proposed | Piezon Master 700
K093000 | EMS miniPiezon
K953026 |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The PIEZON 150 is a device for delivering ultrasonic
movement and water to a stainless steel tip which is used
by a dentist or dental hygienist. The indications for use
are:
• Periodontal pocket lavage with simultaneous
ultrasonic tip movement
• Scaling and root planning
• Removal of supra and subgingival calculus and stains
from teeth
• Intended for use in dental and periodontal applications
performed by an ultrasonic scaler. | The PIEZON 150 is a device for delivering ultrasonic
movement and water to a stainless steel tip which is used
by a dentist or dental hygienist. The indications for use
are:
• Periodontal pocket lavage with simultaneous
ultrasonic tip movement
• Scaling and root planning
• Removal of supra and subgingival calculus and stains
from teeth
• Intended for use in dental and periodontal applications
performed by an ultrasonic scaler. | The Piezon Master 700 is an
ultrasonic scaler intended for
use in the following dental
and periodontal applications:
• Removing supra and
subgingival calculus
deposits and stains from
teeth
• Periodontal pocket lavage
with simultaneous
ultrasonic tip movement
• Scaling and root planing
• Releasing crowns, bridges,
inlays, and posts as well as
condensing gutta percha
• Plugging for amalgam
condensation
• Amalgam burnishing
• Preparing, cleaning and
irrigating root canals
• Cavity preparation
• Cementing inlays and
onlays
• Retrograde preparation of
root canals | The miniPiezon is a
device for delivering
ultrasonic movement and
water to a stainless steel
tip which is used by a
dentist or dental
hygienist. The
indications for use are:
• Periodontal pocket
lavage with
simultaneous ultrasonic
tip movement
• Scaling and root
planning
• Removal of supra and
subgingival calculus
and stains from teeth
• Intended for use in
dental and periodontal
applications performed
by an ultrasonic scaler. |
| Treatment Site | Subgingival and
supragingival | Subgingival and
supragingival | Subgingival and
supragingival | Subgingival and
supragingival |
| Function | Ultrasonic scaling | Ultrasonic scaling | Ultrasonic scaling | Ultrasonic scaling |
| Mechanism of action | Ultrasonic energy | Ultrasonic energy | Ultrasonic energy | Ultrasonic energy |
| Components | • Control Unit
• Foot pedal
• Piczon Handpiece*
• Instruments+
• Water hose with screwed
connector on device | • Control Unit
• Foot pedal
• Piezon Handpiece*
LED
• Instruments+
• Water hose with
screwed connector
on device | • Control Unit
• Foot pedal
• Piezon Handpiece LED
• Instruments*
• Irrigation liquid bottle | • Control Unit
• Foot pedal
• Universal Piezon
Handpiece
• Instruments+
• Water hose with
quick connector on
device |
| Power supply | • External 30V transformer
• 50-60 Hz | • External 30V
transformer
• 50-60 Hz | • Internal transformer 24V
• 50-60 Hz | • External 24V
transformer
• 50-60 Hz |
| Ultrasonic power
adjustment | Power control knob using a
potentiometer | Power control knob
using a potentiometer | Touch sensitive zones on
front panel of housing | • Adjustment key "-"
or "+" on the panel
of housing |
Comparison Table for Determination of Substantial Equivalence PIEZON 150, EMS miniPiezon, and Piezon Master 700
E.M.S. ELECTRO MEDICAL SYSTEMS S.A. Additional Information - K132443
October 24, 2013
CONFIDENTIAL APPENDIX C - Page 4 of 5
4
| Item for
Comparison | PIEZON 150
(FT-215#)
Piezon Handpiece
Proposed | PIEZON 150
(FT-223#)
Piezon Handpiece
LED
Proposed | Piezon Master 700
K093000 | EMS miniPiezon
K953026 |
|--------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Water adjustment | • Connection to external
water supply
• Rotating knob for control
of water flow rate | • Connection to
external water
supply
• Rotating knob for
control of water
flow rate | • Rotary ring on handpiece
hose | • Connection to external
water supply
• Rotating knob for
control of water flow
rate |
| Output performance
specifications | • Maximum output: 8Watts
• Frequency range: 24-32
kHz | • Maximum output:
8Watts
• Frequency range: 24-
32 kHz | • 0-12W (max. power
delivered is 8W)
• 24 - 32 kHz | • Maximum output: 8
W
• Frequency range: 25-
32kHz |
| Power range | • Standard: 0-100%
• Perio0-37.5% | • Standard: 0-100%
• Perio0-37.5% | • Standard:0-100%
• Endo: 0 - 50% | 0-100% |
*Previously cleared in K093000
*Previously cleared in K093000
*All instruments previously cleared (see Section 3)
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines extending from its body, representing the department's commitment to health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular fashion around the eagle symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 22, 2013
E.M.S. Electro Medical Systems S.A. C/O Aptiv Solutions Ms. Cynthia J.M. Nolte Director, Medical Device Regulatory Services 62 Forest Street, Suite 300 Marlborough, MA 01752
Re: K132443
Trade/Device Name: PIEZON 150 Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: Product Code: ELC Dated: October 24, 2013 Received: October 25, 2013
Dear Ms. Nolte:
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 warrantics. 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.
6
Page 2 - Ms. Nolte
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 device-related 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 Small Manufacturers. International and Consumer Assistance at its tollfree 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" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Mary BDAner-S
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known):
Device Name: PIEZON 150
Indications for Use:
The PIEZON 150 is a device for delivering ultrasonic movement and water to a stainless steel tip which is used by a dentist or dental hyglenist. The indications for use are:
- Periodontal pocket lavage with simultaneous ultrasonic tip movement .
- . Scaling and root planing
- Removal of supra and subgingival calculus and stains from teeth .
Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runner -S
FDA 21
08.15.1996 -05'00'