(85 days)
No
The description focuses on heating and vibration mechanisms, temperature regulation based on tip type, and standard device operation, with no mention of AI or ML terms or functionalities.
No
The device is used to process gutta percha and cut plastic handles, which are procedural steps rather than direct treatment or therapy. Its function is to provide heat and/or vibration to a dental instrument, not to directly treat a patient's condition.
No
The device description and intended use clearly state that the device is a dental instrument heater designed for processing gutta percha and cutting plastic handles during root canal treatment. It provides heat and/or vibration to aid in these physical manipulations, not to diagnose any condition or disease.
No
The device description explicitly states it is a "battery-operated dental instrument heater" and describes physical components like a handpiece, tips, and a charger, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide heat and/or vibration to a dental instrument for processing gutta percha and cutting plastic handles during root canal treatment. This is a therapeutic/procedural use, not a diagnostic one.
- Device Description: The description focuses on the physical function of heating and vibrating a dental instrument. It does not mention any analysis of biological samples or diagnostic information.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely focused on assisting with a dental procedure.
N/A
Intended Use / Indications for Use
The intended use of the dental instrument heater – The EndoTwinn - is to provide continuous heat and/or vibration at the tip of a dental instrument. The EndoTwinn is designed for processing gutta percha (cutting softening, spreading, compacting) and cutting plastic handles of obturators during a root canal treatment The device may only be operated by dentists and endodontists.
Product codes
872, 3850, EKM
Device Description
The device is a battery-operated dental instrument heater which is designed to provide continuous heat and/or vibration at the tip of a dental instrument. The low frequency vibration stimulates the transformation of gutta percha in a solid mass. The temperature is regulated by the type of tip attached to the handpiece and it automatically maintains a preset temperature for consistent results. The cordless handpiece is easily operated by a single button and can be recharged by placing the handpiece in a charger. The tips are autoclavable and the handpiece can be disinfect with 80% alcohol.
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 and endodontists.
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)
The devise is tested thoroughly and it complies to the standards for this class II a medical device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 872.3850 Gutta percha.
(a)
Identification. Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
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Image /page/0/Picture/0 description: The image shows a document titled "FDA - 510(k) Application - EndoTwinn". The document number is E1-FDAApplicationv7, and the version is 7. The date is September 17th, 2004, and the author is FV. The review is by FV, and the approval is by signature.
042270 1. 510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
Name, Address, Phone and Fax number of the Applicant A.
EndoTwinn B.V. Danzigerkade 17 1013 AP Amsterdam The Netherlands Telephone: +31 20 486 7571 Fax: +31 20 486 3280
- Contact Person B. Frank Verhoeven
- C. Date Prepared June 2004
Device Name D.
Trade Name: EndoTwinn Classification Name: 8723850 - ( TV Regulation Number and Product Code: 872, 3850 Classification Panel: Dental
E. Device Description
The device is a battery-operated dental instrument heater which is designed to provide continuous heat and/or vibration at the tip of a dental instrument. The low frequency vibration stimulates the transformation of gutta percha in a solid mass. The temperature is regulated by the type of tip attached to the handpiece and it automatically maintains a preset temperature for consistent results. The cordless handpiece is easily operated by a single button and can be recharged by placing the handpiece in a charger. The tips are autoclavable and the handpiece can be disinfect with 80% alcohol.
F. Intended Use
The intended use of the dental instrument heater – The EndoTwinn - is to provide continuous heat and/or vibration at the tip of a dental instrument. The EndoTwinn is designed for processing gutta percha (cutting softening, spreading, compacting) and cutting plastic handles of obturators during a root canal treatment The device may only be operated by dentists and endodontists.
Substantial Equivalence G.
The dental instrument heater is substantially equivalent to several other legally marketed devices in the United States. The dental instrument heater marketed by Sybron functions in a manner similar to and is intended for the same use as the EndoTwinn.
Predicate Devices:
Device Testing Results and Conclusion H.
The devise is tested thoroughly and it complies to the standards for this class II a medical device.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
JAN 1 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Endo Twinn B.V. C/O Mr. J.A. Van Vugt Responsible Third Party Official Kema Quality B.V. 4377 County Line Road Chalfont, Pennsylvania 18914
Re: K042870
Trade/Device Name: Endo Twinn Regulation Number: 872.3850 Regulation Name: Gutta Percha Regulatory Class: I Product Code: EKM Dated: December 28, 2004 Received: December 30, 2004
Dear Mr. Vugt:
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 approvisions 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 (1 Writ), it hay be add of Federal Regulations, Title 21, Parts 800 to 898. In your device oan or roublish further announcements concerning your device in the Federal Register.
2
Page 2 - Mr. Vugt
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. or the Act of all , I out 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 and insting (21 es read in the quality systems (QS) regulation (21 CFR Part 820); and if requirence as bet form 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) Fins feter will fine in J . 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), 11 Joe contact the Office of Compliance at (301) 594-0115. 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 yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
(unknown) 510(k) Number:
EndoTwinn Device Name:
Indications for Use:
The intended use of the dental instrument heater – The EndoTwinn - is to provide continuous heat and/or The intended use of the uental instrument. The EndoTwinn is designed for processing gutta performation in the may be vibration at the up of a dentin instrument. The election and outlers during a root canal treatment The softening, spreading, och perated by dentists and endodontists.
Prescription Use: YES (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use: NO (21 CFR 807 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runnr
(Division Sign-Off) Civision of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K942876
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