(244 days)
Not Found
No
The provided text describes a dental ultrasonic scaler with various intended uses related to calculus removal, periodontal lavage, and root canal procedures. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on the mechanical function of the device.
Yes
The device's intended uses, such as removing calculus deposits, periodontal pocket lavage, and root canal preparation, are all therapeutic interventions aimed at treating dental conditions.
No
Explanation: The Intended Use/Indications for Use describe procedures for removing calculus, lavage, and preparing/cleaning root canals, which are therapeutic or treatment-based actions, not diagnostic ones.
No
The intended use describes procedures involving physical interaction with teeth and root canals (removing calculus, lavage, preparing/cleaning/irrigating root canals). These actions inherently require a physical device (likely an ultrasonic scaler) to perform the described functions, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses described (removing calculus, periodontal pocket lavage, root canal procedures) are all performed directly on the patient's body (in vivo). IVDs are used to examine specimens taken from the body (in vitro), such as blood, urine, or tissue samples.
- Device Description: While the description is "Not Found," the intended use clearly points to a device used for dental procedures within the mouth.
- No mention of analyzing biological samples: There is no indication that this device is used to analyze any biological samples.
Therefore, this device is a dental instrument used for procedures within the mouth, not an IVD.
N/A
Intended Use / Indications for Use
Model :UDS-J/K/N1/N2 :
- Removing supra and sub gingival calculus deposits and stains from the teeth
- Periodontal pocket lavage with simultaneous ultrasonic tip movement
Model: UDS-L :
- Removing supra and sub gingival calculus deposits and stains from the teeth
AND/OR - Periodontal pocket lavage with simultaneous ultrasonic tip movement
- Preparing, cleaning, and irrigating root canals
- Retrograde preparation of root canals
Product codes (comma separated list FDA assigned to the subject device)
ELC
Device Description
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized depiction of an eagle or bird-like figure with three distinct heads or sections, suggesting a sense of unity or collaboration. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
AUG 2 1 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Guilin Woodpecker Medical Instrument Company, Limited C/O Mr. Charlie Mack Principal Engineer International Regulatory Consultants 340 Shady Grove Road Flintville, Tennessee 37335
Re: K053555
ﮨﺴ ﺮ
Trade/Device Name: Ultrasonic Scaler, Models UDS-J, UDS-K, UDS-N1, UDS-N2 Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: August 9, 2006 Received: August 18, 2006
Dear Mr. Mack:
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 me road application (PMA). You may, therefore, market the device, subject to the general approvisions 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 (1 Mr.), it may 80 ode of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2 -- Mr. Mark
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 vour 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,
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
2
Indications for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: __ Ultrasonic Scaler, Models UDS-J, UDS-K, UDS-L, UDS-N1, UDS-N2
Indications For Use:
Model :UDS-J/K/N1/N2 :
-
Removing supra and sub gingival calculus deposits and stains from the teeth
-
Periodontal pocket lavage with simultaneous ultrasonic tip movement
Model: UDS-L :
-
- Removing supra and sub gingival calculus deposits and stains from the teeth
AND/OR
- Removing supra and sub gingival calculus deposits and stains from the teeth
-
Periodontal pocket lavage with simultaneous ultrasonic tip movement
-
Preparing, cleaning, and irrigating root canals
-
Retrograde preparation of root canals
Prescription Use X X (Part 21 CFR 801 Subpart D)
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)
Sincerly
n of Anesthesiology, General Hospital, on Control, Dental Device
) Number: 105 335K
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