(93 days)
Not Found
No
The description focuses on ultrasonic scaling technology with pre-set power modes and user adjustments, with no mention of AI or ML.
Yes
It is intended for dental applications like periodontics, endodontics, scaling, and prosthesis, which are therapeutic procedures.
No
The device description indicates that the Pmax Newtron XS is an ultrasonic scaler used for dental applications like periodontics, endodontics, scaling, and prosthesis. These are treatment-oriented procedures, not diagnostic ones.
No
The device description clearly outlines hardware components such as an ultrasonic scaler, piezoelectric ultrasound technology, solution tanks, an LED handpiece, and connections for air distribution, indicating it is a physical medical device with integrated technology, not software-only.
Based on the provided information, the Pmax Newtron XS is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Pmax Newtron XS Function: The Pmax Newtron XS is an ultrasonic scaler used by dental practitioners for procedures performed directly on the patient's teeth and gums (periodontics, endodontics, scaling, prosthesis). It uses mechanical vibrations and irrigation, not the analysis of biological specimens.
- Intended Use: The intended use clearly describes dental applications performed within the patient's mouth, not laboratory testing of samples.
Therefore, the Pmax Newtron XS falls under the category of a dental device used for treatment and procedures performed directly on the patient, not an IVD.
N/A
Intended Use / Indications for Use
The Pmax Newtron XS is intended for use by qualified dental practitioners in the following dental applications: Periodontics Endodontics Scaling Prosthesis
Product codes (comma separated list FDA assigned to the subject device)
ELC
Device Description
The Pmax Newtron XS is an ultrasonic scaler for use by qualified dental practitioners in the four conventional dental applications of prophylaxis, periodontics, endodontics, and prosthesis.
The Pmax Newtron XS device uses piezoelectric ultrasound technology to generate mechanical microvibrations for ultrasonic scaling, with minimal trauma to soft tissue.
The Pmax Newtron XS™ function offers four utilization modes at pre-set ultrasound power settings. The power of the ultrasound can be finely adjusted by the user.
| Range | Ultrasound power | Procedure |
|---|---|---|
| Green | Low | Periodontics mainly |
| Yellow | Medium | Endodontics mainly |
| Blue | High | Prophylaxis mainly |
| Orange | Very high | Prosthesis or Specific treatment modalities |
Liquid irrigation is provided by two 300 mL self-contained solution tanks and the Newtron LED handpiece provides light and air functions. The light is provided by a light ring consisting of high-performance light-emitting diodes (LED) in the handpiece and air is delivered to the handpiece for air irrigation through connection of the control unit to the user's dental surgery's medical quality filtered air distribution system.
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
qualified dental practitioners
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
§ 872.4850 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
Steve Salesky
21
AUG 2 4 2007
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 9. SMDA Summary of Safety and Effectiveness - "510(k) Summary" | A AND - AN A - AND - - - CARRANT ------- | |
|---|---|---|---|
| - Call Children Commended on Children Children C. Children Comments of |
- A. Submitter Information
SATELEC Z.I. du Phare, BP 30216 17, Avenue Gustave Eiffel 33708 Merignac Cedex FRANCE
Telephone: 011 33 556 34 0607 Fax: 011 33 556 34 9292
Contact Person:
SATELEC c/o Acteon, Inc. 124 Gaither Drive, Suite 140 Mt. Laurel, NJ 08054 Telephone: 800 289-6367 Ext. 40 Fax: 856 222-4726 E-mail: steve.salesky@us.acteongroup.com
Date Prepared: May 11, 2007
B. Device Identification
Common Usual Name: Ultrasonic scaler
Proprietary Name: Pmax Newtron XS
C. Identification of Predicate Device
Device Applicant 510(k) No. Date Cleared Suprasson® P5 Newtron Satelec K050895 April 20, 2005
The Satelec Pmax Newtron XS is substantially equivalent to the predicate device by Satelec, the Suprasson® P5 Newtron (K050895) previously cleared by the FDA and currently marketed.
D. Device Description
The Pmax Newtron XS is an ultrasonic scaler for use by qualified dental practitioners in the four conventional dental applications of prophylaxis, periodontics, endodontics, and prosthesis.
The Pmax Newtron XS device uses piezoelectric ultrasound technology to generate mechanical microvibrations for ultrasonic scaling, with minimal trauma to soft tissue.
The Pmax Newtron XS™ function offers four utilization modes at pre-set ultrasound power settings. The power of the ultrasound can be finely adjusted
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2032
22
by the user.
| Range | Ultrasound power | Procedure |
|---|---|---|
| Green | Low | Periodontics mainly |
| Yellow | Medium | Endodontics mainly |
| Blue | High | Prophylaxis mainly |
| Orange | Very high | Prosthesis or Specific |
| treatment modalities |
Liquid irrigation is provided by two 300 mL self-contained solution tanks and the Newtron LED handpiece provides light and air functions. The light is provided by a light ring consisting of high-performance light-emitting diodes (LED) in the handpiece and air is delivered to the handpiece for air irrigation through connection of the control unit to the user's dental surgery's medical quality filtered air distribution system.
E. Substantial Equivalence
The Pmax Newtron XS and the predicate device, Suprasson® P5 Newtron (K050895) are both ultrasonic scalers for use in conventional dentistry by qualified dental practitioners. Differences that exist between the devices relating to technical specifications, performances and intended use are minor and do not affect the safety and effectiveness of the Pmax Newtron XS.
2
Image /page/2/Picture/11 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SATELEC C/O Mr. Steve Salesky Quality Manager Acteon, Incorporated 124 Gaither Drive, Suite 140 Mount Laurel, New Jersey 08054
AUG 2 4 2007
Re: K071424
Trade/Device Name: Pmax Newtron XS Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: August 13, 2007 Received: August 15, 2007
Dear Mr. Salesky:
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. Salesky
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suptile K. Michael Duis
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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Indications for Use
510(k) Number:
Device Name:
Pmax Newtron XS
Indications for Use:
The Pmax Newtron XS is intended for use by qualified dental practitioners in the following dental applications:
Periodontics Endodontics Scaling Prosthesis
Please refer to the attached listing for a detailed description.
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)
Suse Riser
(Civision Sign-Off) Livision of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K171461
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K071424
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INDICATIONS FOR USE Pmax Newtron XS
Periodontics:
- Root planing .
- . Initial therapy
- Treatment of periodontal pockets .
- Treatment of furcations .
- Maintenance therapy .
- . Implant maintenance
Endodontics:
- Canal preparation .
- Canal cleaning ●
- . Canal filling
- Gutta percha condensation .
- . Treatment resumption
- Retro Surgery .
- Micro Retro Surgery .
Scaling (prophylaxis):
- . Interdental junction treatment
- Tooth neck and subgingival treatment .
- . Treatment of large deposits
- Treatment of coating and tobacco stains .
- Interproximal treatment .
Prosthesis (conservative/restorative):
- . Inlay/onlay condensation
- Amalgam plugging .
- Loosening prostheses (bridge, crown, post, pivot ... ) .