(55 days)
Not Found
NOT APPLICABLE
No
The summary describes a mechanical dental contra-angle and makes no mention of AI or ML.
No
The device is a dental contra-angle, which is a tool used for dental procedures, not a therapeutic device. It performs mechanical work ("low speed dental works") rather than directly treating a disease or condition therapeutically.
No
Explanation: The device, a dental contra-angle, is described as allowing "to carry out all low speed dental works" and receiving various dental instruments (burs, prophylaxis instruments, endodontic instruments). This strongly suggests it is an operative or treatment device, not one used for diagnosis. There is no mention of it collecting information for analysis or aiding in identifying a condition or disease.
No
The device description and intended use clearly describe a physical dental contra-angle, which is a hardware component. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a dental contra-angle used on dental motors for various low-speed dental procedures. This involves working directly on the patient's teeth and mouth.
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Lack of IVD Characteristics: The description does not mention any analysis of biological specimens or providing diagnostic information based on such analysis.
Therefore, this device falls under the category of a dental instrument used for treatment and procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
These contra-angles are intended for use on dental motors equipped with a coupling according to ISO Standard 3964. The speed of the motors may not exceed 40 000 RPM. These contra-angles may receive all dental instruments for contra-angles (burs, prophylaxis instruments, endodontic instruments) whose shank is of type 1, such as : determined in ISO Standard 1797. They allow to carry out all low speed dental works Their usage is of course reserved to dentists or hygienists who are duly graduated and entitled to exercise.
Product codes
EGS
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
dentists or hygienists
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)
Not Found
Reference Device(s)
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines forming the body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 4 1997
Ms. Jean-Marie Badoz MICRO-MEGA SA 5-12 rue du Tunnel - unn 25006 Besancon FRANCE
K971350 Re : Series XE, Series SE Series TE Trade Name: Requlatory Class: I Product Code: EGS Dated: April 1, 1997 Received: April 10, 1997
Dear Ms. Badoz:
We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your
1
Page 2 - Ms. Badoz
premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 of (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
2
510(k) Number (if known):
Device Name:
Indications For Use:
CONTRA-ANGLES 04 XE - 06 XE - 08 XE 04 SE - 06 SE - 08 SE 04 TE - 06 TE - 08 TE
These contra-angles are intended.for use. on dental motors equipped with a coupling according to ISO Standard 3964.
The speed of the motors may not exceed 40 000 RPM.
These contra-angles may receive all dental instruments for contra-angles (burs, prophylaxis instruments, endodontic instruments) whose shank is of type 1, such as : determined in ISO Standard 1797.
They allow to carry out all low speed dental works
Their usage is of course reserved to dentists or hygienists who are duly graduated and entitled to exercise.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runsey
(Division Sign Off)
(Division Sign-Off) Division of Dental, Infection Controll, and General Hospital Devices 510(k) Number K9
Prescription Usey (Per 21 CFR 801.109)
OR
Over-The-Counter Use ------
(Optional Format 1-2-96)