(7 days)
No
The device description focuses on the physical principles of ultrasonic scaling (electromagnetic field, magnetostrictive inserts, vibration) and electrical specifications. There is no mention of AI, ML, image processing, or data-driven algorithms.
Yes
The device is used for scaling, debridement, and endodontic procedures, all of which are medical treatments for dental conditions.
No
The device, an ultrasonic scaler, is described for therapeutic procedures (scaling, debridement, endodontic procedures) and does not mention any diagnostic functions such as detection, diagnosis, or assessment of a medical condition.
No
The device description clearly outlines physical hardware components (Cavitron RF Product, ultrasonic inserts, handpiece) that generate and transmit ultrasonic energy for dental procedures. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes procedures performed directly on the patient's teeth and gums (scaling, debridement, endodontic procedures). IVDs are used to examine specimens from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The device description details an ultrasonic scaler that physically interacts with the patient's dentition. It does not describe any components or processes for analyzing biological samples.
- Anatomical Site: The anatomical site is the "human dentition," which is the area where the device is used directly on the patient. IVDs analyze samples taken from the body, not the body itself.
The device is a dental instrument used for therapeutic and cleaning procedures within the mouth, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
Used for ultrasonic procedures: 1) All general supra and subgingival scaling applications; 2) Childement for all types of periodontal diseases; and 3) Endodontic procedures Used for ultrasonic procedures: - All general supra and subgingival scaling applications . - An general supra ament for all types of periodontal diseases . - Endodontic procedures .
Product codes
ELC
Device Description
The Modified Device, the Model G131 consists of the Cavitron RF DE VIC E DESCRIPTION. The Product, and the applicable model families of Cavitron 30K Ultrasonic Inserts.
The Model G-131 Cavitron RF Utrasonic Scaler with Sterimate handpiece is a 30K ultrasonic The Model (1) 127 Carriros an electrical signal to the detachable, sterilizable handpiece. The dental device that provides an electroniagnetic field, pulsed at 30 kilohertz (KHz) through the length of the handpiece. When a magnetostrictive insert, designed to resonate near 30kHz is the length of the handpiece it will vibrate at the designed resonance which in turn excites the miserica mito and namapleed in reciprocal motion. The system operates over a frequency range working top, causing it to strent voltage of the Scaler is 100 - 240 VAC, 50 to 60 Hz
The Cavitron RF magnetostrictive ultrasonic TECTINOENON AT - OHARA - EFRE rounter top use to mechanically debride (remove tartar) Scanny system is a dovree intention system drives an ultrasonic insert designed with a resonate from numan deather. The seating by and in the distal end of the insert tip. The trequency wouldes a means for control of power (tip stroke) and lavage flow rates. The system is system provides a means for comrer minicates through a RF link or through an auxillary hardwired cable. The footswitch has two positions which activates a water solenoid or ultrasonic energy to the handpiece.
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)
DENTSPLY Cavitron SPS Scaler System, Model G-119 (K970123)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K052334
510(k) SUMMARY
SEP - 2 2005
DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872
| CONTACT: | Helen Lewis |
|---|---|
| DATE PREPARED: | August 23, 2005 |
| TRADE OR PROPRIETARY NAME: | Model G-131, CAVITRON ® RF Ultrasonic Scaler System with Sterimate Handpiece |
| CLASSIFICATION NAME: | Ultrasonic scaler 872.4850 |
| PREDICATE DEVICES: | DENTSPLY Cavitron SPS Scaler System, Model G-119 (K970123) |
DEVICE DESCRIPTION: The Modified Device, the Model G131 consists of the Cavitron RF DE VIC E DESCRIPTION. The Product, and the applicable model families of Cavitron 30K Ultrasonic Inserts.
The Model G-131 Cavitron RF Utrasonic Scaler with Sterimate handpiece is a 30K ultrasonic The Model (1) 127 Carriros an electrical signal to the detachable, sterilizable handpiece. The dental device that provides an electroniagnetic field, pulsed at 30 kilohertz (KHz) through the length of the handpiece. When a magnetostrictive insert, designed to resonate near 30kHz is the length of the handpiece it will vibrate at the designed resonance which in turn excites the miserica mito and namapleed in reciprocal motion. The system operates over a frequency range working top, causing it to strent voltage of the Scaler is 100 - 240 VAC, 50 to 60 Hz
INTENDED USE: Used for ultrasonic procedures: 1) All general supra and subgingival scaling INTEATED OFF. OSC 10/ USC 10/ Childement for all types of periodontal diseases; and 3) Endodontic procedures
TECHNOLOGICAL CHARACTERISTICS: The Cavitron RF magnetostrictive ultrasonic TECTINOENON AT - OHARA - EFRE rounter top use to mechanically debride (remove tartar) Scanny system is a dovree intention system drives an ultrasonic insert designed with a resonate from numan deather. The seating by and in the distal end of the insert tip. The trequency wouldes a means for control of power (tip stroke) and lavage flow rates. The system is system provides a means for comrer minicates through a RF link or through an auxillary hardwired cable. The footswitch has two positions which activates a water solenoid or ultrasonic energy to the handpiece.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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 an abstract symbol that resembles a stylized human figure with three flowing lines representing the body and arms.
Public Health Service
SEP - 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Helen Lewis Mis. Helen Bowls
Director of Corporate Compliance and Regulatory Affairs Susquehanna Commerce Center West 221 West Philadelphia Street York, Pennsylvania 17404
Re: K052334
Trade/Device Name: Cavitron RF Ultrasonic Scaler System with Sterimate Handpiece Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic scaler Regulatory Class: II Product Code: ELC Dated: August 23, 2005 Received: August 26, 2005
Dear Ms. Lewis:
We have reviewed your Section 510(k) premarket notification of intent to market the devices We have reviewed your Section 910(x) premainer's substantially equivalent (for the indications referenced above and nave decembined the marketed predicate devices marketed in interstate for use stated in the encrosule for regary maneted povice Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Medical Forley of Food. Fored Freed, Dry commerce prior to May 20, 1976, the encordance with the provisions of the Federal Food. Drug. devices that have been reclassified in acceraance was a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval or o and Cosment Act (Act) that do not requent appen o the general controls provisions of the Act. The You may, merelore, market the devree, basjeer to the see annual registration, listing of general controls provisions of the free head. I see in the more of the misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classifica (sec above) into exist in the subscriptions affecting your device can
may be subject to such additional controls. Existing major regulations ED may be subject to such additional controller Entibility of Controller. be found in the Code of Peaces oncerning your device in the Federal Register.
2
Page 2 - Ms. Lewis
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA $ issualles of a substition on the requirements of the Act
that FDA has made a determination that your device complies . You must that FDA has made a decemination that your as roos of her Federal agencies. You must and list or any Federal statules and regulations daministers. by registration and listing (21
comply with all the Act's requirements, including, but not limited to set comply with all the Act s requirements, moradial ware and one of the requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing as and CFR Part 807); labeling (21 CFR Part 800); good and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the elect forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050 product radiation control provisions (Sections of Perice as described in your Section 510(k)
This letter will allow you to begin marketing your device of your daying to legal This letter will anow you to ocgin mancemig of substantial equivalence of your device to a legally premarket notification. The FDA midnig of substantial equives 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
rs the received in the most of 115 at the couls to reculption entitled If you desire specific advice for your de not on our said the regulation entitled, they may obtain contact the Office of Complaned at (210) 276-6601" (21CFR Part 807.97). You may obtain " Misbranding by relevelec to premarket notificalled in the Act from the Division of Small other general information on your responsible the toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at and Cincludes attindex attack Manufacturers, International and Colisanier Fishows.cda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Michie Oms.
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
3
Image /page/3/Picture/0 description: The image shows the text "K052334" in a handwritten style. The text is underlined. Below the line is the text "INDICATIONS FOR USE STATEMENT".
510(K) Number (if known):
Device Name: Model G-131, CAVITRON® RF ULTRASONIS SCALER SYSTEM
PRODUCTION CONSECTED CATE HANDRIECE WITH STERIMATE HANDPIECE
Indications for Use:
Used for ultrasonic procedures:
- All general supra and subgingival scaling applications .
- An general supra ament for all types of periodontal diseases .
- Endodontic procedures .
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)
Susan Suarez
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K052334