(92 days)
No
The description focuses on the mechanical aspects of the handpiece (reciprocating movement, speed, torque) and performance testing related to mechanical and sterilization properties. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
This device is an attachment for root canal preparation, which is a dental procedure. While it aids in a therapeutic process, the device itself is a tool or accessory rather than a standalone therapeutic device that directly treats a condition or disease.
No
The device description indicates it is a handpiece attachment for root canal preparations and endodontic treatment, which are therapeutic procedures, not diagnostic ones.
No
The device description clearly describes a physical handpiece attachment with mechanical components (reciprocating vertical vibrating mechanism, drive speed, torque, friction grip) and performance studies related to physical properties (chuck friction grip, resistance to sterilizing procedure, temperature rise, corrosion, sodium hypochlorite exposure). There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue taken from the human body to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The RDT3 Handpiece Head is a dental handpiece attachment used for mechanical preparation of root canals during endodontic treatment. It physically interacts with the tooth structure and a file to shape the canal.
- Lack of Biological Sample Analysis: The device does not analyze any biological samples (blood, tissue, etc.) to provide diagnostic information. Its function is purely mechanical and procedural.
Therefore, based on its intended use and description, the RDT3 Handpiece Head falls under the category of a medical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
RDT3 Handpiece Head is a reciprocating dental handpiece attachment intended for use in root canal preparations using the Self Adjusting File, SAF (ReDent Nova LTD., Ra'anana lsrael).
Product codes (comma separated list FDA assigned to the subject device)
EFA
Device Description
RDT3 handpiece attachment is compatible with the KaVo GENTLE power low-speed handbiece. The RDT3 is able to operate the SAF during root canal treatment procedures, while working with continuous sodium hypochlorite irrigation. RDT3 is a reciprocating vertical vibrating handpiece attachment and is capable of providing the SAF with an impact movement of approximately 0.4 mm and up to 5,000 rpm drive speed required for conducting endodontic treatment. Low torque (max 9.5 ar cm) rotation motion is integrated in order to ease insertion of the file into the root canal. The file is attached to the RDT3 head via friction grip.
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
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)
Performance tests were carried out to evaluate the properties of the RDT3. The tests were carried in accordance with ISO 7785-2 Dental Handpieces Part 2: Straight and Geared Angle Handpieces:
- Handpiece head Chuck Friction Grip
- Handpiece Head Resistance to Sterilizing Procedure
- Handpiece Head Temperature Rise
- Handpiece Head Resistance to Corrosion
In addition Redent performed an In-house test: - Handpiece Head Sodium Hypochlorite Exposure ●
In all instances the RDT3 functioned as intended and results observed were as expected.
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.
Intra Lux Head 3LDSY (K092446)
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.
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
§ 872.4200 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
K 101172
510(k) SUMMARY REDENT NOVA's RDT3 Handpiece Head
Submitter's Name, Address, Telephone Number, Contact Person: and Date Prepared
Hogan Lovells US LLP Phone: (202) 637-5600 Facsimile: (202) 637-5910
Contact Person: Jonathan S. Kahan
Date Prepared: July 21, 2010
Name of Device and Name/Address of Sponsor:
RDT3 Handpiece Head
Redent Nova Ltd. 15 Hataasia street P.O.B 4159 Ra'anana 43000, Israel
Common or Usual Name
Handpiece head attachment
Classification Name
| Name: | Dental Handpiece and Accessories |
|---|---|
| Product code: | EFA |
| Classification regulation: | 872.4200 |
| Class: | I |
| Panel: | Dental |
Predicate Devices
Intra Lux Head 3LDSY (K092446)
Intended Use / Indications for Use
RDT3 Handpiece Head is a reciprocating dental handpiece attachment intended for use in root canal preparations using the Self Adjusting File, SAF (ReDent Nova LTD., Ra'anana lsrael).
Technological Characteristics
RDT3 handpiece attachment is compatible with the KaVo GENTLE power low-speed handbiece. The RDT3 is able to operate the SAF during root canal treatment procedures, while working with continuous sodium hypochlorite irrigation.
JUL 2 7 2010
| --
1
RDT3 is a reciprocating vertical vibrating handpiece attachment and is capable of providing the SAF with an impact movement of approximately 0.4 mm and up to 5,000 rpm drive speed required for conducting endodontic treatment. Low torque (max 9.5 ar cm) rotation motion is integrated in order to ease insertion of the file into the root canal.
The file is attached to the RDT3 head via friction grip.
Performance Data
Performance tests were carried out to evaluate the properties of the RDT3.
The tests were carried in accordance with ISO 7785-2 Dental Handpieces Part 2: Straight and Geared Angle Handpieces:
- � Handpiece head Chuck Friction Grip
- Handpiece Head Resistance to Sterilizing Procedure .
- . Handpiece Head Temperature Rise
- . Handpiece Head Resistance to Corrosion
In addition Redent performed an In-house test:
- Handpiece Head Sodium Hypochlorite Exposure ●
In all instances the RDT3 functioned as intended and results observed were as expected.
Substantial Equivalence
The RDT3 is substantially equivalent to the Intra Lux Head 3LDSY (manufactured by KaVo GmbH & Co (Sybron Dental Specialties Inc)). The RDT3 has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the RDT3 and its predicate device identified below raises no new issues of safety or effectiveness.
The technological and operational differences between the RDT3 and its predicate are:
- . Higher maximal drive speed.
- . RDT3 has a low torque 360° rotation motion whereas the 3LDSY has a free 360° rotation.
- . Different means of attaching the file to the handpiece head.
- . Different materials used for internal components.
These differences do not raise new questions of safety or efficacy. Additionally, performance testing in compliance with ISO 7785-2 demonstrates that the RDT3 is comparable to the Intra Lux Head 3LDSY. Accordingly, the RDT3 is substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and three wavy lines extending from the eagle's body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Redent Nova Limited C/O Mr. Jonathan S. Kahan Hogan Lovells US LLP Columbia Square, 555 13th Street, NW Washington, District of Columbia 20004
. The 8 2010
Re: K101172
Trade/Device Name: RDT3 Handpiece Head Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFA Dated: July 21, 2010 Received: July 21, 2010
Dear Mr. Kahan:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
3
Page 2- Mr. Kahan
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,
Susan Quinn
Anthony D. Watson, B.S., M.S., M.B.A. 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
510(k) Number (if known): _
Device Name:
JUL 27 2010
RDT3 Handpiece Head
Indications for Use:
RDT3 Handpiece Head is a reciprocating dental handpiece attachment intended for use in root canal preparations using the Self Adjusting File, SAF (K092933) (ReDent Nova LTD., Ra'anana Israel).
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ren Muhy
(Division Sign-Off) Page __ of ___________________________________________________________________________________________________________________________________________________________________ Division of Anestnesiology, General Hospital Infection Control, Dental Devices
Number: K101172