(55 days)
Not Found
None
No
The summary does not mention AI, ML, image processing, or any data-driven performance metrics typically associated with AI/ML devices. The description points to a mechanical handpiece.
Yes
The device is described as delivering "rotary root canal preparation treatment" and "polishing outside of teeth after cleaning," both of which are therapeutic procedures performed by licensed dental professionals.
No
The device's intended use is for "delivering rotary root canal preparation treatment" and "polishing outside of teeth." These are treatment or therapeutic procedures, not diagnostic ones.
No
The device description explicitly states "LightSpeed Cordless Endodontic Handpiece," which is a hardware device. The intended use also describes a physical action (delivering rotary root canal preparation treatment, polishing outside of teeth) performed by a handpiece.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- This device is used directly on the patient's teeth and root canals for treatment (preparation and polishing). It is a therapeutic and procedural device, not a diagnostic one that analyzes biological samples.
The intended use and device description clearly indicate it's a tool for performing dental procedures, not for analyzing biological specimens.
N/A
Intended Use / Indications for Use
This device is for use only by a licensed dentist for the purpose of delivering rotary root canal preparation treatment only. Device may also be used by licensed dental hygienist for polishing outside of teeth after cleaning.
Product codes
EKX
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
licensed dentist, licensed dental hygienist
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
Image /page/0/Picture/1 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 stripes forming its wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA", which is arranged in a circular fashion around the eagle.
MAY - 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Steven Senia President LightSpeed Technology, Incorporated 403 East Ramsey, Suite 205 San Antonio, Texas 78216
Re: K050612
Trade/Device Name: LightSpeed Cordless Endodontic Handpiece Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EKX Dated: March 10, 2005 Received: March 10, 2005
Dear Mr. Senia:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed yoursely and have determined the device is substantially equivalent (for the referenced above and nave acterinalisaure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device micrstate conmisered prior to tray ave been reclassified in accordance with the provisions of Amendinents, on to de rises that in to o act (Act) that do not require approval of a premarket the rederal I ood, Drug, and Ocenters , therefore, market the device, subject to the general approval application (1 Mary) - The general controls provisions of the Act include controls provisions of a 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 If your device is classified (oss as additional controls. Existing major regulations affecting (I MA), it may be subject to back of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Sous nouncements concerning your device in the Federal Register.
1
Page 2 - Mr. Senia
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 moan mat i Drimas made statutes and regulations administered by other Federal agencies. of the Act of ally I oderal statutes and submitten to: but not limited to: registration 1 ou must configry with and heveling (21 CFR Part 801); good manufacturing practice and listing (21 CF R Fart 807), abolity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in are quadion 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) This letter will and if yourse 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), If you desire specific at no Compliance at (240) 276-0115. 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 may overn of Small Manufacturers, International and Consumer Assistance at its toll-free Driber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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
2
Indications for Use
510(k) Number (if known): K050612
Device Name: LightSpeed Cordless Endodontic Handpiece
Indications for Use:
This device is for use only by a licensed dentist for the purpose of delivering rotary root canal preparation treatment only. Device may also be used by licensed dental hygienist for polishing outside of teeth after cleaning.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ken Hurley for MSR
(Dausion Sign-Off) Online of Anesthesiology, General Hospital, Infection Control, Dental Devices
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