(96 days)
Not Found
No
The summary describes a standard electric motor system for dental procedures and does not mention any AI or ML components or functionalities.
No
Explanation: A therapeutic device is used to treat a disease or condition. This device is used for cutting, shaping, filing, drilling, cleaning, and polishing procedures in dentistry, which are primarily procedural and not direct treatment of a disease or condition itself. While these procedures may be part of a treatment plan, the device itself is a tool for mechanical manipulation, not a therapeutic agent.
No
The device description states its use for "cutting, shaping, filing, drilling, cleaning and polishing procedures," which are treatment-oriented rather than diagnostic.
No
The device description explicitly lists hardware components such as an electric motor, control unit, AC power supply, connector hose, and attachments.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cutting, shaping, filing, drilling, cleaning and polishing procedures" in general and endodontic dentistry. This describes a mechanical device used for physical manipulation within the mouth, not for testing samples outside the body to diagnose conditions.
- Device Description: The description details an "electric motor driven dental handpiece system" with various attachments. This aligns with a tool used for dental procedures, not a diagnostic test.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), performing tests, or providing diagnostic information based on biological or chemical analysis.
IVD devices are specifically designed 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
Used in general dentistry and endodontic dentistry for cutting, shaping, filing, drilling, cleaning and polishing procedures
Product codes
EFB
Device Description
The eSTYLUS™ ELECTRIC MOTOR SYSTEM is an electric motor driven dental handpiece system with various attachments, intended for use in general and endodontic dentistry. The System includes the electric motor, control unit, AC power supply, connector hose, and contra-angle and straight attachments.
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
Not Found
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.
0
510(k) SUMMARY
JUL 1 5 2003
NAME & ADDRESS:
Y International
Vest College Avenue Box 877 PA 17405-0872 dentsplv.com
P. J. Lehn Telefax (717) 849-4343
CONTACT: P. Jeffery Lehn
DATE PREPARED: April 9, 2003
TRADE OR PROPRIETARY NAME: eSTYLUS™ ELECTRIC MOTOR SYSTEM
CLASSIFICATION NAME: Dental handpieces and accessories (872.4200)
PREDICATE DEVICES:
Bien-Air's Dental Handpieces K983183 TCM Endo III Dental Handpiece K013185
DEVICE DESCRIPTION: The eSTYLUS™ ELECTRIC MOTOR SYSTEM is an electric motor driven dental handpiece system with various attachments, intended for use in general and endodontic dentistry. The System includes the electric motor, control unit, AC power supply, connector hose, and contra-angle and straight attachments.
The eSTYLUS™ ELECTRIC MOTOR SYSTEM is designed for use in INTENDED USE: general dentistry and endodontic dentistry for cutting, shaping, filing, cleaning and polishing procedures.
1
510(k) SUMMARY (cont'd.)
TECHNOLOGICAL CHARACTERISTICS: The eSTYLUS™ ELECTRIC MOTOR SYSTEM is substantially equivalent to Bien Air's dental handpieces and Nouvag's TCM Endo III dental handpiece. They have the same intended uses, basic technology, primary energy source, and materials. Similar materials, features,
We believe that the similarities to legally marketed predicate devices, the comparison and performance data provided, and the testing conducted support the safety and effectiveness of the eSTYLUS™ ELECTRIC MOTOR SYSTEM for the intended uses.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes representing the department's mission of promoting health, well-being, and human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 15 2003
Mr. P. Jeffery Lehn Director of Compliance & Regulatory Affairs DENTSPLY International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872
Re: K031145
Trade/Device Name: eSTLUSTM ELECTRIC MOTOR SYSTEM Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: April 9, 2003 Received: April 16, 2003
Dear Mr. Lehn:
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.
3
Page 2 – Mr. Lehn
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 (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.
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), please contact the Office of Compliance at (301) 594-4613. 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/dsma/dsmamain.html
Sincerely vours.
Susan Runo
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
(As Required by 21 CFR 807.87(e)
510(K) Number (if known):
Device Name:
eSTYLUS™ ELECTRIC MOTOR SYSTEM
Indications for Use:
Used in general dentistry and endodontic dentistry for cutting, shaping, filing, drilling, cleaning and polishing procedures
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
r
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Kein Mulvey for MSB
eral Hospital,
510(k) Num
7