(25 days)
Not Found
No
The description focuses on mechanical improvements (swivel mechanism, grip) and performance studies evaluate cleaning effectiveness and handling, with no mention of AI/ML terms or functionalities.
Yes
The device is described as being used for "dental cleaning and periodontal (gum) therapy to remove calculus from the teeth," which are therapeutic actions aimed at treating or preventing disease.
No
The device is used for dental cleaning and periodontal therapy to remove calculus from the teeth, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states the device is an "ultrasonic insert" with "stainless steel and resin components," indicating it is a physical hardware device, not software.
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 (gum) therapy to remove calculus from the teeth." This is a therapeutic procedure performed directly on the patient's teeth, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a physical instrument used for mechanical removal of calculus. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnostic purposes (identifying a disease or condition)
This device falls under the category of a dental instrument used for treatment.
N/A
Intended Use / Indications for Use
To be used by Dental Professionals for dental cleaning and periodontal (gum) therapy to remove calculus from the teeth.
Product codes (comma separated list FDA assigned to the subject device)
ELC
Device Description
The Hu-Friedy® brand Satin Swivel™ ultrasonic insert is similar to the predicate device with the addition of a swivel mechanism allowing for ease of rotational movement during dental cleaning procedures. This device is intended to be used by dental professionals for dental cleaning and periodontal therapy to remove calculus from the teeth. The Satin Swivel™ ultrasonic insert has essentially the same internal design as the predicate device except for the addition of several stainless steel and resin components. The steel components enable the insert tip to swivel. The two different resin components allow for a positive grip for the dental professional and a smooth cone to tip transition for ease of use.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
To determine if the Satin Swivel™ ultrasonic insert performed similar to or better than the predicate device both laboratory and a field evaluation were undertaken. The laboratory tests included cleaning, sterilization, and mechanical life testing. For the field study clinicians were asked to evaluate the inserts as related to scaling effectiveness, vibration, water delivery, swivel function, and grip. The overall conclusion of this evaluation was that both the Satin Swivel™ and the predicate device met their clinical requirements. The clinicians had complete control of the Satin Swivel™ ultrasonic insert and it did not turn on its own while in use.
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
JUL 27 2001
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
6/29/01 Date Prepared
Device Name
| Trade name | Satin Swivel™ Ultrasonic Insert |
|---|---|
| Common name | Ultrasonic Insert |
| Classification name | Ultrasonic Scaler |
Legally marketed Device to which equivalence is claimed
Hu-Friedy Ultrasonic Scaler Insert K953919
Description of the device
The Hu-Friedy® brand Satin Swivel™ ultrasonic insert is similar to the predicate device with the addition of a swivel mechanism allowing for ease of rotational movement during dental cleaning procedures.
This device is intended to be used by dental professionals for dental cleaning and periodontal therapy to remove calculus from the teeth.
The Satin Swivel™ ultrasonic insert has essentially the same internal design as the predicate device except for the addition of several stainless steel and resin components. The steel components enable the insert tip to swivel. The two different resin components allow for a positive grip for the dental professional and a smooth cone to tip transition for ease of use.
1
To determine if the Satin Swivel™ ultrasonic insert performed similar to or better than the predicate device both laboratory and a field evaluation were undertaken. The laboratory tests included cleaning, sterilization, and mechanical life testing. For the field study clinicians were asked to evaluate the inserts as related to scaling effectiveness, vibration, water delivery, swivel function, and grip. The overall conclusion of this evaluation was that both the Satin Swivel™ and the predicate device met their clinical requirements. The clinicians had complete control of the Satin Swivel™ ultrasonic insert and it did not turn on its own while in use.
2
Image /page/2/Picture/2 description: The image shows a black and white logo for the Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a traditional symbol of medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 7 2001
Mr. Keith Dunn Manager of Regulatory Affairs Manager of Regulacor), Incorporation 3232 North Rockwell Street Chicago, Illinois 60618
K012060 Re : Hu-Friedy Brand Satin Swivel Trade/Device Name: Ultrasonic Insert Regulation Number: 872.4850 Regulatory Class: II Product Code: ELC Dated: June 29, 2001 July 2, 2001 Received:
Dear Mr. Dunn:
We have reviewed your Section 510(k) notification of intent to we have reviewed your beceren above and we have determined the market the device fererenous above indications for device is subblancially ore) to legally marketed predicate use stated in the chorobase, commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to che enactment date or choclassified in accordance with the devices that have been al Food, Drug, and Cosmetic Act (Act).
provisions of the Federal Food, Drug, and Cosmetic the general provisions of the reactur rood, bray, asubject to the general The general controls controls provisions of the Act. controls provisions of include requirements for annual provisions of the not insteasines, 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 (Premarket Approval), it may (Special Concrols) additional controls. Existing major be subject to bacting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A rederal hegaturents. Ifree termination assumes compliance with subscancially equivalence aring Practice requirements, as set the Current Sood handsustem Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, beview. Scholar QS inspections, the Food and Drug chrough periodic go inbecurity such assumptions. Failure to Administration (121) Egulation may result in regulatory In addition, FDA may publish further announcements action.
3
Page 2 - Mr. Dunn
concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
A. Ulatowski Timot Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page__________________________________________________________________________________________________________________________________________________________________________ of
510(k) Number (if known): K012060
Device Name: Hu-Friedy Brand Satin Swivel Ultrasonic Insert
Indications For Use:
To be used by Dental Professionals for dental cleaning and periodontal (gum) therapy to remove calculus from the teeth.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runser
Division Sign-Off) ison of Dental, Infection Control, Caneral Hospital Devices Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)