(151 days)
No
The summary describes a dental ultrasonic generator using piezoelectric technology and makes no mention of AI or ML.
Yes
The device is described as being "designed for the treatment of scaling (prophylaxis), periodontics, endodontics and prosthesis (preservation and restoration dentistry)," which indicates a therapeutic purpose.
No
The device is described as a dental ultrasonic generator used for treatments like scaling, periodontics, and endodontics, which are therapeutic procedures, not diagnostic ones.
No
The device description explicitly states it is a "Dental Ultrasonic Generator" and uses "Piezoelectric Technology," indicating it is a hardware device that generates ultrasound. It also mentions using a handpiece and dental tips, which are physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for dental procedures (scaling, periodontics, endodontics, prosthesis) performed directly on a patient. This involves physical intervention and treatment within the oral cavity.
- Device Description: The description details a "Dental Ultrasonic Generator" that uses piezoelectric technology and is used with a handpiece and tips. This aligns with a device used for generating ultrasonic vibrations for dental treatments.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, urine, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This device is designed for direct therapeutic and prophylactic treatment within the body.
N/A
Intended Use / Indications for Use
The medical device is used in association with a dental ultrasound handpiece to which an ultrasound instrument is attached. It is designed for the treatment of scaling (prophylaxis), periodontics, endodontics and prosthesis (preservation and restoration dentistry).
Product codes (comma separated list FDA assigned to the subject device)
ELC
Device Description
The Satelec New Device is a Dental Ultrasonic Generator. The Sateler New Device uses Piezoelectric Technology.The Satelec New Device uses a Satelec Dental Piezoelectric Plezonecht - Technology. The Satelec New Device can use the same Handpiece Harroplece (NEWTRON OElin). In Option the School (K050895, cleared April 20, 2005).
The Satelec New Device is designed to be used with Satelec Dental Tips previously cleared with The Satelec New Device is Gesigned to be association of the St. 430, cleared February 23, 2012) or other new Satelec Dental Tips.
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
Not Found
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
Section 006 - 510(k) Summary (SMDA Requirements) Additional Information - September 17, 2013
This Summary of Safety And Effectiveness is submitted in accordance with 21 CFR 807.92.c.
01 - Administrative Information
01- a. Type of 510(k) submission:
These documents constitute a Traditional 510(k) Submission.
June 24, 2013 Submission date: 01- b.
NOV 26 2013
510(k) Submitter 01-c.
SATELEC 17, Avenue Gustave Eiffei BP 30216 33708 Merignac Cedex France 011-33-556-340-607 Telephone: 011-33-556-349-292 Fax: philippe.girard@acteongroup.com E-Mail:
01-d. Contact Person:
Rick Rosati SATELEC c/o ACTEON, Inc. 124 Gaither Drive, Suite 140 Mt. Laurel, NJ 08054 800-289-6367 Ext. 390 Telephone: 856-222-4726 Fax: rick.rosati@us.acteongroup.com E-Mail:
8044015 01- e. Establishment Registration Number:
02 - Device Information
| 02-a. Trade Name of Device: | NEWTRON BOOSTER |
|---|---|
| 02-b. Common Name of Device: | Ultrasonic Scaler |
| 02-c. Classification Regulation: | 21 CFR 872.4850 |
| 02-d. Medical Device Class: | II |
| 02-e. Panel: | Dental |
| 02-f. Product Code: | ELC |
Pre-Market Notification 510(k) Submission for NEWTRON BOOSTER By SATELEC Kel Nodification of Offy - Confidential Document - Version 01 006 - 1
Image /page/0/Picture/16 description: The image shows a stylized letter G above the text "ISO 13485". The letter G is large and bold, and the text is smaller and located below the letter. The text appears to be a certification or standard identifier.
Image /page/0/Picture/17 description: The image shows the logo for Satelec Acteon. The word "ACTEON" is written in large, bold, black letters. Above the right side of the word "ACTEON" is the word "SATELEC" in smaller letters. To the left of the word "ACTEON" is a black curved line.
SATELEC . A company of ACTEON Group Gustave Elifel . BP 30216 . 33708 MERICNAC cedex . FRANCE
Tel + 33 (0) 556 34 06 07 . Fax + 33 (0) 556 34 97 92 av. Gustave E-mail: satelec@acteontroup.com . www.acteongroup.com Société pour la Conception des Applications des Techniques Electroniques • 5.A.S. au capRel de 1 309 548 6. R.C. Bordelux 8 782 016 240 · N' intracommunataire FR 39 782 016 240
1
Section 006 - 510(k) Summary (SMDA Requirements) Additional Information - September 17, 2013
03 - Identification of Legally Marketed Predicate(s)
The Substantial Equivalence (SE) of the Satelec New Device is based on the Predicate Devices identified in the Table 01.
| Trade Name | Manufacturer | Product
Code | 510(K)
number | Date Cleared |
|---------------------------|--------------|-----------------|------------------|-------------------|
| SUPRASSON P5 NEWTRON | SATELEC | ELC | K020892 | April 20, 2005 |
| ProUltra Piezo Ultrasonic | SATELEC | ELC | K113430 | February 23, 2012 |
Table 01 - Identification of Legally Marketed Predicate Devices
04 - Description of the Device
The Satelec New Device is a Dental Ultrasonic Generator. The Sateler New Device uses Piezoelectric Technology.The Satelec New Device uses a Satelec Dental Piezoelectric Plezonecht - Technology. The Satelec New Device can use the same Handpiece Harroplece (NEWTRON OElin). In Option the School (K050895, cleared April 20, 2005).
The Satelec New Device is designed to be used with Satelec Dental Tips previously cleared with The Satelec New Device is Gesigned to be association of the St. 430, cleared February 23, 2012) or other new Satelec Dental Tips.
05 - Intended Use
The medical device is used in association with a dental ultrasound handpiece to which an ultrasound instrument is attached. It is designed for the treatment of scaling (prophylaxis), periodontics, endodontics and prosthesis (preservation and restoration dentistry).
06 - Technological characteristics of the Device compared to the Predicate Devices
Technological characteristics of the Satelec New Device are the same as the Predicate Device.
Technological Perspective:
The Satelec New Device and the Predicate Devices use the same technology (Piezoelectricity Technology).
Material perspective:
Marelial Device and the Predicate Devices are very similar because the casings are made in self-extinguishing material (UL94V-0).
Pre-Market Notification 510(k) Submission for NEWTRON BOOSTER By SATELEC ket Notification 310(k) - Confidential Document - Version 01
006 - 2
Image /page/1/Picture/18 description: The image shows the logo for Satelec Acteon. The word "ACTEON" is written in large, bold, black letters. Above and to the right of "ACTEON" is the word "SATELEC" in smaller letters. A curved line is to the left of the word "ACTEON".
2
Section 006 - 510/k) Summary (SMDA Requirements)
Additional Information - September 17, 2013
Design perspective:
The Satelec New Device and the Predicate Devices use:
- The same Principle of User interface. .
- The same Dental Ultrasonic Handpiece (Satelec NEWTRON Handpiece) and / or a derivated Dental Ultrasonic Handpiece (Satelec NEWTRON SLIM Handpiece).
Energy source perspective:
The Satelec New Device and the Predicate Devices:
- Use the same input energy source (Electric Power Supply). -
- Deliver the same output energy source (ultrasonic micro-vibration). *
- Deliver the same Handpiece Current Values. "
- Deliver a similar irrigation Flow values. -
07 - Determination of substantial equivalence
The Satelec New Device Indications for Use is similar to the Satelec Predicate Devices. The The Gateleo Non Device is the Satelec Predicate Devices in terms of functioning orinciple.
The Satelec New Device uses a Satelec NEWTRON SLIM Dental Piezoelectric Handpiece. The Satelec NEWTRON SLIM Dental Piezoelectric Handpiece is based on the Satelec Predicate Satelec NEWTRON P5 NEWTRON (K050895, cleared April 20, 2005) and Satelec ProUltra Devices SOT KAOON 1 D Newrod February 23, 2012) (same materials, same Piezoeledric Fransducters). Also, the Satelec New Device can be used with Satelec NEWTRON Handplece employed with SUPRASSON P5 NEWTRON (K050895, cleared April 20, 2005)
From external structure perspective, the Satelec New Device and Predicate Devices are very From external structure perspourve, the Sating How material (UL94-V0). Also, Satelec New Device and Satelec Predicate Devices use a single function footswitch.
Moreover, the materials in contact to the patient are the same.
08 - Conclusion
The Satelec New Device is the same as the identified Predicate Devices in terms of Indication For Use.
Because of the used technologies, characteristics and performances are similar to the Satele Predicate Devices, the characteristics of the Sateler New Device do not affect the Safety of the Predicate Devices, the onarcelenenes of the Effectiveness is the same as of the Predicate Devices.
There is no doubt that the Satelec New Device is Substantially Equivalent (SE) of the Satelec There is no dobb that the Gated February 23, 2012) and Satelec SUPRASSON P5 NEWTRON (K050895, cleared April 20, 2005).
End of Section
Pre-Market Notification 510(k) Submission for NEWTRON BOOSTER By SATELEC K131997 - Traditional 510(k) - Confidential Document - Version 01 006 - 3
Image /page/2/Picture/23 description: The image shows a logo with the letter G in a bold, stylized font. Below the letter G, the text "ISO 13485" is written in a smaller, sans-serif font. The logo appears to be a certification mark, possibly indicating compliance with the ISO 13485 standard for quality management systems in the medical device industry.
Image /page/2/Picture/24 description: The image shows the logo for Satelec Acteon. The word "ACTEON" is in large, bold, black letters. Above and to the right of "ACTEON" is the word "SATELEC" in smaller, less bold letters. To the left of "ACTEON" is a curved line that resembles a crescent moon.
SATELEC . A company of ACTEON Group 17 av. Gustave Eiffel + BP 30216 + 33708 MERKGNAC cedex + FRANCE
E-mail: satelec@acteongroup.com · www.acteongroup.com Société pour la Conception des Applications des Techniques Electroniques » 5.A.S. Iu capital de 1 309 548 € R.C. Bordeaux B 782 016 240 · Nº Intracommunautaire FR 39 782 016 240
3
Section 006 - 510(k) Summary (SMDA Requirements)
Additional Information - September 17, 2013
This page is intentionally left in blank
Pro-Market Notification 510(k) Submission for NEWTRON BOOSTER By SATELEC Kel NotifiedIon B10(k) - Confidential Document - Version 01 006 - 4
Image /page/3/Picture/4 description: The image shows the text "ISO 13485" in a sans-serif font. Above the text is a large letter "G" in bold font. The letter "G" is slightly tilted to the right. The text and the letter "G" are in black color.
SATELEC
ACTEON
17 av, Gustave SATELE - A Conquily of ACTEON Grap
4
Image /page/4/Picture/0 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 that resembles a caduceus, a traditional symbol of medicine, with three wavy lines representing the branches of the department.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 26, 2013
Satelec-Acteon Group Mr. Rick Rosati Quality Manager C/O ACETON, Incorporated 124 Gaither Drive, Suite 140 Mt. Laurel, NJ 08054
Re: K131997
Trade/Device Name: NEWTRON BOOSTER Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: November 1, 2013 Received: November 4, 2013
Dear Mr. Rosati:
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.
5
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 YowIndustry/default.htm.
Sincerely yours,
Image /page/5/Picture/7 description: The image shows the name "Kwame Ulmer" in a stylized font. The name "Kwame" is stacked on top of "Ulmer" on the left side of the image. To the right of the name is a logo that includes the letters "EDA" and a triangle shape.
for
Erin Keith 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
6
Section 005 - Indication for Use Additional Information - September 17, 2013
Indications for Use
510(k) Number (if known):_K131997
Device Name:
:
NEWTRON BOOSTER
Indications for Use:
The medical device is used in association with a dental ultrasound handpiece to which an ultrasound instrument is attached. It is designed for the treatment of scaling (prophylaxis), periodontics, endodontics and prosthesis (preservation and restoration dentistry).
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) Kwame O. Ulmerss 2013.11.27 15:58 469 0500
Concurrence of CDRH, Office of Device Evaluation (ODE)
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