(77 days)
Not Found
Not Found
No
The 510(k) summary describes a physical medical device (ultrasonic tips) and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is described as being used for root preparation procedures to make space for filling material, which is a procedural/surgical function rather than a therapeutic one designed to treat or alleviate a disease or condition itself.
No
Explanation: The device is described as being used for "endodontic root preparation procedures" to "make space for permanent filling material," which indicates a therapeutic or interventional function, not a diagnostic one.
No
The device description explicitly states the tips are composed of stainless steel with a layer of fine diamond particles, indicating a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Ultrasonic Tips with Diamond Coating are used in endodontic root preparation procedures within the patient's mouth. This is a surgical or procedural device used directly on the patient's anatomy, not for testing samples outside the body.
The information provided focuses on the device's use in a clinical procedure, its composition, and its intended anatomical site, all of which are characteristic of a medical device used in vivo (within the living body), not in vitro (in glass/outside the body).
N/A
Intended Use / Indications for Use
The Ultrasonic Tips with Diamond Coating are utilized in endodontic root preparation procedures which includes retro-prep of root ends in order to make space for permanent filling material in the canal.
Product codes
ELC
Device Description
The Ultrasonic Tips with Diamond Coating are utilized in endodontic root preparation procedures which includes retro-prep of root ends in order to make space for permanent filling material in the canal. The tips are composed of stainless steel with a layer of fine diamond particles.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Sybron Endo/Analytic, Ultrasonic Tips
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
5 2002 JUL
Image /page/0/Picture/1 description: The image shows the logo for SDS on the left side. The logo is black and has a stylized font. On the right side of the image, the text "K021253" is written in black ink. There is a line drawn underneath the text.
Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
Sybron Dental Specialties, Inc. 1717 West Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 – Facsimile Colleen Boswell - Contact Person
Date Summary Prepared: April 2002
Device Name:
- Trade Name Ultrasonic Tips with Diamond Coating .
- Common Name Ultrasonic Tips .
- Classification Name Ultrasonic Scaler, per 21 CFR § 872.4850 .
Devices for Which Substantial Equivalence is Claimed:
- . Sybron Endo/Analytic, Ultrasonic Tips
Device Description:
The Ultrasonic Tips with Diamond Coating are utilized in endodontic root preparation procedures which includes retro-prep of root ends in order to make space for permanent filling material in the canal. The tips are composed of stainless steel with a layer of fine diamond particles.
Intended Use of the Device:
The intended use of the Ultrasonic Tips with Diamond Coating is for endodontic root preparation procedures which includes retro-prep of root ends in order to make space for permanent filling material in the canal.
Substantial Equivalence:
Ultrasonic Tips with Diamond Coating is substantially equivalent to other legally marketed devices in the United States. Ultrasonic Tips with Diamond Coating functions in a manner similar to and is intended for the same use as the Ultrasonic Tips marketed by Sybron Endo/Analytic.
1717 West Collins Avenue, Orange, CA 92867 800-537-7824 714-516-7400
1
Image /page/1/Picture/1 description: The image is a black and white circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which is a stylized image of three human profiles facing right, with flowing lines above them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
5 2002 JUL -
Sybron Endo/Analytic C/O Ms. Colleen Boswell Director, Corporate Compliance Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867
Re: K021253
Trade/Device Name: Ultrasonic Tips with Diamond Coating Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: April 16, 2002 Received: April 19, 2002
Dear Ms. Boswell:
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.
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.
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.
2
Page 2 - Ms. Boswell
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 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Qusz L./or
Timothy A. Ulatowski
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Section I
Indications for Use Statement
Ver/ 3 - 4/24/96
Applicant: Sybron Endo/Analytic
510(k) Number (if known):
K021253
Device Name: Ultrasonic Tips with Diamond Coating
Indications For Use:
The Ultrasonic Tips with Diamond Coating are utilized in endodontic root preparation
procedures which includes retro-prep of root ends in order to make space for permanent filling
material in the canal.
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number
K021253
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
(Optional Format 1-2-96)