(85 days)
No
The summary describes a mechanical dental handpiece attachment and does not mention any software, algorithms, or data processing that would indicate the presence of AI/ML.
No.
The device is described as an attachment for use in root canal preparations using hand-held endodontic files, which is a procedural tool rather than a device designed to treat or alleviate a disease or condition. Its function is to facilitate a dental procedure, not to provide therapy directly.
No
The device description clearly states its purpose is for "root canal preparations using hand-held endodontic files," indicating a therapeutic or procedural function, not a diagnostic one.
No
The device description clearly states it is a "reciprocating dental handpiece attachment," which is a physical hardware component used in dentistry.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "root canal preparations using hand-held endodontic files." This is a mechanical procedure performed directly on the patient's tooth structure.
- Device Description: The description details a mechanical attachment for a dental handpiece used for physical manipulation within the root canal.
- Lack of IVD Characteristics: 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 does not interact with or analyze such specimens.
The device is a tool used in a dental procedure, not a diagnostic test performed on a biological sample.
N/A
Intended Use / Indications for Use
The INTRA Lux Head 3 LDSY reciprocating dental handpiece attachment is intended for use in root canal preparations using hand-held endodontic files.
Product codes
EFA
Device Description
The INTRA Lux Head 3 LDSY reciprocating dental handpiece attachment is for use by a trained professional in general dentistry. The device is attached to air-powered or electrical handpieces. The reciprocating dental handpiece attachment is re-usable and ergonomically shaped, and can be sterilized by the steam autoclave method.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
root canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professional in general dentistry
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)
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
Section III - 510(k) Summary of Safety and Effectiveness
1"
Image /page/0/Picture/2 description: The image shows the logo for "sybron dental specialties". The text is in a bold, sans-serif font and is black. A curved line is above the text.
Submitter:
NOV - 8 2009
Sybron Dental Specialties, Inc. 1717 West Collins Drive Orange, CA 92656 Claudia Ortiz - Contact Person
Date Summary Prepared: August 2009
Device Name:
- Trade Name -- INTRA Lux Head 3 LDSY .
- Common Name Dental Handpiece Attachment .
- Classification Name -- Handpiece, contra- and right-angle attachment, dental, per 21 ● CFR § 872.4200
Devices for Which Substantial Equivalence is Claimed:
- A-Dec Inc., A-dec/W&H Synea Profin Reciprocating Contra-Angle Handpiece ● Attachments WA-67/0.4 LT, WA-67/0.4 A (K082827)
- . Micro Motors Inc., EndoPulse Reciprocating Handpiece (K896878)
Device Description:
The INTRA Lux Head 3 LDSY reciprocating dental handpiece attachment is for use by a trained professional in general dentistry. The device is attached to air-powered or electrical handpieces. The reciprocating dental handpiece attachment is re-usable and ergonomically shaped, and can be sterilized by the steam autoclave method.
Intended Use of the Device:
The INTRA Lux Head 3 LDSY reciprocating dental handpiece attachment is intended for use in root canal preparations using hand-held endodontic files.
Substantial Equivalence:
The INTRA Lux Head 3 LDSY is substantially equivalent to other legally marketed devices in the United States. The intended use of the devices is identical to that of the predicate devices. The INTRA Head 3 LDSY is substantially equivalent in design, application and function to the A-dec/W&H Synea Profin Reciprocating Contra-Angle Handpiece Attachments WA-67/0.4 LT, WA-67/0.4 A marketed by A-Dec Inc., and to the EndoPulse Reciprocating Handpiece marketed by Micro Motors. Inc. (now Endo Technic).
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular seal on the left and a stylized symbol on the right. The circular seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. The symbol on the right resembles a stylized human figure with arms outstretched, possibly representing care or assistance.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Kaltenbach & Voigt GmbH & Company C/O Ms. Claudia Ortiz Compliance Director, Regulatory Affairs Sybron Dental Specialties, Incorporated 1717 West Collins Drive Orange, California 92867
NOV - 3 2009
Re: K092446 .
Trade/Device Name: INTRA Lux Head 3 LDSY Regulation Number: 21CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFA Dated: August 7, 2009 Received: August 10, 2009
Dear Ms. Ortiz:
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 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.
2
Page 2- Ms. Ortiz
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/Safety/ReportaProblem/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,
h for
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image shows the text "K092446" in a handwritten style, followed by the words "Indications for Use" in a bold, sans-serif font. The handwritten text appears to be a code or identifier, while the phrase below suggests the image is related to instructions or guidelines for a product or procedure. The contrast between the handwritten and printed text creates a visual hierarchy, with the code likely serving as a reference point for the subsequent instructions.
510(k) Number (if known):
Device Name: INTRA Lux Head 3 LDSY
Indications for Use:
The INTRA Lux Head 3 LDSY reciprocating dental handpiece attachment is intended for use in root canal preparations using hand-held endodontic files.
Prescription Use X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kein Mulvey for WSL
(Division Sign-Off) Division of Anesthesiology, General Hospital .. nection Control, Dental Devices
Page 2 of 21 510(k) Number:
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