(155 days)
Not Found
No
The summary describes a set of passive, mechanical tips for an ultrasonic handpiece. There is no mention of any software, algorithms, or data processing that would indicate the presence of AI or ML. The performance studies are mechanical testing, not related to algorithmic performance.
Yes
The device is intended for the removal of soft and hard tissue during endodontic root canal preparation procedures and aids in the removal of endodontic posts and other intra-canal blockages, which are therapeutic actions.
No.
The "Intended Use / Indications for Use" section states that the device is for "removal of soft and hard tissue during endodontic root canal preparation procedures" and aiding in "removal of endodontic posts and other intra-canal blockages," which describes a therapeutic or procedural function, not a diagnostic one.
No
The device description explicitly states that the device is an accessory to a piezoelectric ultrasonic handpiece and scaler unit and that the tips themselves are made of stainless steel. This indicates a physical, hardware-based device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the removal of soft and hard tissue during endodontic root canal preparation procedures, and aiding in the removal of posts and blockages. This is a surgical/procedural use, not a diagnostic one.
- Device Description: The device is an accessory to an ultrasonic handpiece and scaler unit, used for mechanical action within the root canal. This aligns with a surgical tool, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
- Performance Studies: The performance study mentioned is mechanical testing (breakage resistance), which is relevant for a surgical tool's durability, not for diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
EDS Ultrasonic Tips are intended for use by dental professionals for the removal of soft and hard tissue during endodontic root canal preparation procedures. They can also aid in the removal of endodontic posts and other intra-canal blockages.
Product codes (comma separated list FDA assigned to the subject device)
ELC
Device Description
EDS Ultrasonic Tips are an accessory to a piezoelectric ultrasonic handpiece and scaler unit. These powered components are not included as part of the device submitted for application with the 510(k) submission. EDS Ultrasonic Tips are stainless steel and will be available in M3x0.5 and #5-40 thread with 6 different tip designs. 1 tip design is devised for post removal; the remaining 5 tips are designed for negotiating the various angles and directions of root canals.
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
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)
Mechanical testing was conducted in the form of breakage resistance testing to determine the appropriate shelf life for EDS Ultrasonic Tips.
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
K132609/5003
Section 5 - 510(k) Summary
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
-
- Submitter's Identification: Essential Dental Systems 89 Leuning Street South Hackensack, NJ 07606
Date Summary Prepared: December 19, 2013
- Submitter's Identification: Essential Dental Systems 89 Leuning Street South Hackensack, NJ 07606
Contact: Mr. Jeffrey Wan Contact Email: jwan@edsdental.com Contact Phone #: 201-487-9090 ext. 118 Contact Fax #: 201-487-5120
2. Name of the Device:
Trade name: EDS Ultrasonic Tips Common name: Scaler, Ultrasonic (Ultrasonic Tips) CFR Number: 872.4850 ું તે Device class: Class II Product Code: ELC
3. Predicate Device Information:
- Sapphire Plus® Tips, San Diego Swiss Machining, K960889.
4. Device Description:
EDS Ultrasonic Tips are an accessory to a piezoelectric ultrasonic handpiece and scaler unit. These powered components are not included as part of the device submitted for application with the 510(k) submission. EDS Ultrasonic Tips are stainless steel and will be available in M3x0.5 and #5-40 thread with 6 different tip designs. 1 tip design is devised for post removal; the remaining 5 tips are designed for negotiating the various angles and directions of root canals.
5. Intended Use:
EDS Ultrasonic Tips are intended for use by dental professionals for the removal of soft and hard tissue during endodontic root canal preparation procedures. They can also aid in the removal of endodontic posts and other intra-canal blockages.
1
6. Comparison to Predicate Devices:
A comparison of the EDS Ultrasonic Tips and the 510(k) cleared Sapphire Plus® Tips indicates the following similarities and differences to the device which received 510(k) clearance:
EDS Ultrasonic Tips are similar to the predicate device Sapphire Plus® Tips in that they are both stainless steel tips used in conjunction with piezoelectric scalers and handpieces to remove soft and hard tissue during root canal preparation procedures.
EDS Ultrasonic Tips are different from the predicate device in the specific design geometry. While thev both include a handle with a common attachment to most English and/or Metric piezoelectric units, the contour of the tips differ in thickness, length, and curvature. Furthermore, EDS Ultrasonic Tips are made of a different alloy of stainless steel and do not exhibit a coating.
| Proposed Device | Predicate Device #1 | |
|---|---|---|
| 510(k) | K132609 | K960889 |
| Device Name | EDS Ultrasonic Tips | Sapphire Plus® Tips |
| Manufacturer | Essential Dental Systems | San Diego Swiss Machining |
| Intended Use | Remove soft and hard | |
| tissue during endo root | ||
| canal prep. Remove | ||
| endodontic posts and other | ||
| intra-canal blockages | Reconstructive dental | |
| procedures, crown prep, | ||
| perio prep, root prep | ||
| Composition | 316 Stainless steel | 13-8 Stainless steel |
| Operational Principles | Used in conjunction with | |
| piezoelectric ultrasonic | ||
| handpiece and scaler. | ||
| Ultrasonic energy vibrates | ||
| tip at high frequencies (up | ||
| to 40,000 Hz) | Used in conjunction with | |
| piezoelectric ultrasonic | ||
| handpiece and scaler. | ||
| Ultrasonic energy vibrates | ||
| tip at high frequencies (up to | ||
| 40,000 Hz) | ||
| Coating(s) | None | Titanium Nitride |
| Zirconium Nitride |
Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as Follows:
Substantial equivalence of the EDS Ultrasonic Tips to the predicate device is based on a comparison of indications, intended uses, and materials. Mechanical testing was conducted in the form of breakage resistance testing to determine the appropriate shelf life for EDS Ultrasonic Tips.
8. Discussion of Clinical Tests Performed:
Not Applicable
2
9. Conclusions:
. . . . .
. .
.
EDS Ultrasonic Tips are substantially equivalent to the currently cleared and marketed Sapphire Plus® Tips.
: .
.
. . . . . . . . . . . . . . .
:
"
1
Company of the count
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's logo, which consists of a stylized caduceus symbol. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the logo.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 22, 2014
Essential Dental Systems Mr. Jeffrey Wan Research and Development Manager 89 Leuning Street South Hackensack, NJ 07606
Re: K132609
Trade/Device Name: EDS Ultrasonic Tips Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: December 19, 2013 Received: December 20, 2013
Dear Mr. Wan:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
4
Page 2 - Mr. Wan
.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/4/Picture/6 description: The image contains a signature and some text. The text includes the name "Tejashri Purohit-Sheth, M.D." followed by "Clinical Deputy Director" and "DAGRID". The word "FOR" is at the bottom right of the image.
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Section 4 - Indications for Use
510(k) Number (if known): K132609
Device Name: EDS Ultrasonic Tips
Indications for Use:
EDS Ultrasonic Tips are intended for use by dental professionals for the removal of soft and hard tissue during endodontic root canal preparation procedures. They can also aid in the removal of endodontic posts and other intra-canal blockages.
Prescription Use X (Per 21 CFR 801 Subpart D)
OR
Over the Counter Use (Per 21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------05 PA 2014.01.22 15:47:45-05'00'