(79 days)
Not Found
No
The device description and performance studies focus on the mechanical and functional aspects of an ultrasonic scaling tip, with no mention of AI or ML technologies.
Yes
The device is described as being used for "dental cleaning and periodontal (gum) therapy to remove calculus, plaque and staining of the teeth" and "to remove calculus from the teeth," which aligns with therapeutic purposes.
No
The device is described as an ultrasonic scaling tip used for dental cleaning and periodontal therapy to remove calculus, plaque, and staining. Its function is to remove existing material, not to diagnose a condition or disease.
No
The device description clearly describes a physical, ultrasonic scaling tip used for dental procedures, not a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for dental cleaning and periodontal therapy to remove calculus, plaque, and staining from teeth. This is a therapeutic and procedural use, not a diagnostic one.
- Device Description: The device is a scaling tip that uses ultrasonic vibration to physically remove material from the teeth. This is a mechanical action, not a test performed on a sample taken from the body to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (like blood, urine, tissue, etc.) or providing information for the diagnosis of a disease or condition.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic purposes. This device operates in vivo (within the body) and performs a therapeutic action.
N/A
Intended Use / Indications for Use
To be used by Dental Professionals during dental cleaning and periodontal (gum) therapy to remove calculus, plaque and staining of the tecth by application of an ultrasonic vibrating tip to the teeth.
Product codes
ELC
Device Description
The Hu-Friedy® brand Symmetry S-Series Piezo Scaling Tip is similar to the Piezo Scaling Tips used with the predicate devices listed above.
This device is intended to be used by dental professionals for dental cleaning and periodontal therapy to remove calculus from the teeth.
The Symmetry S-Series ultrasonic insert has essentially the same design as the predicate device's ultrasonic inserts. Laboratory tests performed to make this determination include cleaning, sterilization, and mechanical life testing. The key elements of piezoelectric ultrasonic tip compatibility include: correspondence of tip thread to hand-piece specification, tip vibration at resonant frequency established by equipment specification, (27-32 kHz) and a linear tip displacement in a range consistent with the power output setting on the generator. At the conclusion of engineering design control testing, it was found that critical clements of design, resonant frequency and tip displacement are compatible with the predicate device's tips.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental Professionals
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
To determine if the Symmetry S-Series ultrasonic insert performed similar to or better than the predicate device, a field evaluation was undertaken. For the field study, clinicians were asked to evaluate the inserts as related to scaling efficiency, adaptability to the tooth surface, water delivery, patient comfort during use and overall preference.
Summary of Performance Studies
Field study; The overall conclusion of this evaluation was that the Symmetry S-Series tips were perceived to be equal to, or slightly better than the predicate device's competitive tip.
Key Metrics
Not Found
Predicate Device(s)
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
FEB 1 2006
510(k) SUMMARY
| Submitter | Keith Dunn
Hu-Friedy Mfg. Co., Inc.
3232 N. Rockwell St.
Chicago, IL 60618
Tel. 773-975-6100 Fax 773-868-3558 |
| ----------- | --------------------------------------------------------------------------------------------------------------------------- |
|---|
Date Prepared
11/01/05
Device Name
Trade name Common name Classification name
Symmetry S-Series Piezo Scaling Tips Dental Ultrasonic Scaler Ultrasonic Scaler
Legally marketed Devices to which equivalence is claimed:
| Satelec Suprasson P-Max | K942139 |
|---|---|
| Satelec Suprasson P5 Booster | K961158 |
Description of the device
The Hu-Friedy® brand Symmetry S-Series Piezo Scaling Tip is similar to the Piezo Scaling Tips used with the predicate devices listed above.
This device is intended to be used by dental professionals for dental cleaning and periodontal therapy to remove calculus from the teeth.
The Symmetry S-Series ultrasonic insert has essentially the same design as the predicate device's ultrasonic inserts. Laboratory tests performed to make this determination include cleaning, sterilization, and mechanical life testing. The key elements of piezoelectric ultrasonic tip compatibility include: correspondence of tip thread to hand-piece specification, tip vibration at resonant frequency established by equipment specification,
1
(27-32 kHz) and a linear tip displacement in a range consistent with the power output setting on the generator. At the conclusion of engineering design control testing, it was found that critical clements of design, resonant frequency and tip displacement are compatible with the predicate device's tips.
To determine if the Symmetry S-Series ultrasonic insert performed similar to or better than the predicate device, a field evaluation was undertaken. For the field study, clinicians were asked to evaluate the inserts as related to scaling efficiency, adaptability to the tooth surface, water delivery, patient comfort during use and overall preference. The overall conclusion of this evaluation was that the Symmetry S-Series tips were perceived to be equal to, or slightly better than the predicate device's competitive tip.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract design of an eagle with three stripes representing the department's mission to promote health, well-being, and human services. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2006 FEB I
Mr. Keith Dunn Regulatory Affairs Hu-Friedy Manufacturing Company, Incorporated 3232 North Rockwell Street Chicago, Illinois 60618
Re: K053178
Trade/Device Name: Symmetry S-Series Piezoclectric Scaling Tips Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: October 17, 2005 Received: November 17, 2005
Dear Mr. Dunn:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent (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.
3
Page 2 – Mr. Dunn
Please be advised that FDA's issuance of a substantial equivalence determination documot 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) gegulation (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 £21), 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-firee number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Sviette y. N. Mclian Omd.
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
4
Indications for Use
510(k) Number (if known): ..........................................................................
Device Name: Symmetry S-Scries Piczoclectric Scaling Tips
Indications for Use:
To be used by Dental Professionals during dental cleaning and periodontal (gum) therapy to remove calculus, plaque and staining of the tecth by application of an ultrasonic vibrating tip to the teeth.
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
Siber Runoe
"Prov. Canvalla Loch Sans drain 1999 1005
KC53178