(225 days)
Not Found
No
The 510(k) summary describes a mechanical accessory (ultrasonic tips) for a dental handpiece. There is no mention of software, algorithms, data processing, or any terms related to AI/ML. The device's function is purely mechanical/physical.
Yes
The device is used to remove tissue and blockages from the root canal to prepare it for permanent filling, which is a therapeutic intervention.
No
The primary function of the device is to remove tissue and blockages from the root canal, which is a therapeutic intervention rather than a diagnostic one. It assists in preparing the tooth for filling, not in identifying a condition.
No
The device description clearly states that the device is an "accessory to a Piezo ultrasonic hand piece and unit" and describes physical tips with specific shapes and threads, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The AEI Dr. Terauchi Ultrasonic Tips are used directly on the tooth structure (root and canal) during a dental procedure. They are a tool for physical manipulation and removal of tissue and blockages, not for analyzing a specimen taken from the body.
- Intended Use: The intended use clearly states "for endodontic root preparation procedures" and describes their function in removing tissue and blockages within the tooth. This is a procedural tool, not a diagnostic test.
The description and intended use align with a surgical or procedural device used within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AEI Ultrasonic Tips are intended for use by dental professionals for endodontic root preparation procedures. The Ultrasonic Tips can remove soft and hard tissue from a narrow dentinal structure in order to make space for permanent filling material in the canal. They can also assist in the removal of separated instruments or other intra-canal blockages.
Product codes (comma separated list FDA assigned to the subject device)
ELC
Device Description
The AEI Ultrasonic Tips are an accessory to a Piezo ultrasonic hand piece and unit. These external power supplies are not part of the device submitted for application with the 510(k) submission. The Ultrasonic Tips with a concave spoon shape or straight tip are very small and will not cut significant amounts of dentin during use. The AEI Ultrasonic Tips will be available in M3x0.6 thread with 5 different types of tip design to facilitate reaching specific angles and directions in the root of the tooth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
root of the tooth
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)
Clinical evaluations were conducted outside the US and showed that the devices were safe and effective for the proposed indications.
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
1122501
510(k) Summary
MAR 2 9 2013
DATE: August 10, 2012
510(k) SPONSOR: American Eagle Instruments, Inc 6575 Butler Creek Road
· Missoula, MT 59808
CONTACT PERSON:
Kristen Nsytuen Compliance Manager/Engineer (406) 549-7451 knystuen@am-eagle.com
TRADE NAME:
AEI (Dr. Terauchi) Ultrasonic Tips
COMMON NAMES:
CLASSIFICATION, and CLASS:
21 CFR 872.4850, Class II;
Ultrasonic Tips
PRODUCT CODES: ELC
PREDICATE DEVICE:
Company Device DENTSPLY ProUltra® Endo Tips (a.k.a Sapphire Plus® Tips)
510(k) No. K200880
Date Cleared May 10, 1996
DEVICE DESCRIPTION: The AEI Ultrasonic Tips are an accessory to a Piezo ultrasonic hand piece and unit. These external power supplies are not part of the device submitted for application with the 510(k) submission. The Ultrasonic Tips with a concave spoon shape or straight tip are very small and will not cut significant amounts of dentin during use. The AEI Ultrasonic Tips will be available in M3x0.6 thread with 5 different types of tip design to facilitate reaching specific angles and directions in the root of the tooth.
INDICATIONS FOR USE: The AEI Ultrasonic Tips are intended for use by dental professionals for endodontic root preparation procedures. The Ultrasonic Tips can remove soft and hard tissue from a narrow dentinal structure in order to make space for permanent filling material in the canal. They can also assist in the removal of separated instruments or other intra-canal blockages.
1
SUMMARY OF TECHNOLOGIES/SUBSTANTIAL EQUIVALENCE:
A comparison of the AEI Ultrasonic Tips and the currently marketed ProUltra® Endo Tips indicates the following similarities to the device which received 510(k) clearance:
-
- Same technological characteristics
-
- Same operating principle
-
- Similar design features
-
- Same connection capabilities to piezoelectric ultrasonic generator
-
- Same material
NON-CLINICAL TESTING:
Substantial equivalence of the AEI Ultrasonic Tips to the predicate device is based on a comparison of indications, intended use and materials. Mechanical testing was, therefore, not conducted.
CLINICAL TESTING:
Clinical evaluations were conducted outside the US and showed that the devices were safe and effective for the proposed indications.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three bars representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 29, 2013
Ms. Kristen Nystuen Compliance Manager/Management Representative American Eagle Instruments, Incorporated 6575 Butler Creek Road MISSOULA MT 59808
Re: K122501
Trade/Device Name: AEI Dr. Terauchi Ultrasonic Tips™ Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: February 18, 2013 Received: February 26, 2013
Dear Ms. Nystuen:
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.
3
Page 2 - Ms. Nystuen
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Safetv/ReportalProblem/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,
Kwame O. Ulmer -5
for
Anthony D. Watson. B.S., M.S., M.B.A. Director
Division of Anesthesiology. General Hospital, Respiratory, Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
4
Indications for Use Statement
1/2 250) 510(k) Number (if known):
AEI Dr. Terauchi Ultrasonic TipsTM Device Name:
The AEI Dr. Terauchi Ultrasonic Tips are intended for use by dental professionals for endodontic root preparation procedures. The Ultrasonic Tips can remove soft and hard tissue from a narrow dentinal structure in order to make space for permanent filling material in the canal. They can also assist in the removal of separated instruments or other intra-canal blockages.
Prescription Use X (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 (ODE)
Page 1 of 1
Mary S. Runner -S
Susan Runner, DDSMA 2013.03.22 12:24:07 -04'00'
(Division Sign-Off)
Do
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices