(113 days)
Not Found
No
The description focuses on the mechanical properties and operation of the file, with no mention of AI or ML.
No.
The SAF is a tool used for cleaning and shaping root canals, which is a part of a therapeutic procedure, but the device itself directly performs a mechanical action rather than delivering a therapeutic agent or energy to treat a condition.
No
Explanation: The device is described as an endodontic file for cleaning and shaping root canals, which are therapeutic actions, not diagnostic.
No
The device description clearly describes a physical, mechanically operated endodontic file made of metal alloy, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "cleaning and shaping of root canals, as part of the procedure of root canal treatment." This is a mechanical procedure performed directly on the patient's anatomy (root canals).
- Device Description: The device is a "mechanically operated endodontic file" used for physical manipulation within the root canal.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to be used in vitro (in glass, or outside the living organism) to analyze biological samples. This device is used in vivo (within the living organism) for a mechanical procedure.
N/A
Intended Use / Indications for Use
The Self Adjusting file (SAF) is a mechanically operated endodontic file to be used for cleaning and shaping of root canals, as part of the procedure of root canal treatment.
Product codes
EFB
Device Description
The ReDent SAF is an endodontic file that is indicated for use in root canal treatment for cleaning and shaping of the root canal. The file portion of the SAF consists of a metal lattice hollow cylinder and is constructed from medical grade nickel-titanium-alloy. The file's cylindrical lattice structure permits compression when inserted into the root canal followed by gradual radial expansion to fill the root canal profile. The file is surface treated by sandblasting, enabling it to file dentin from the canal's interior surface.
The SAF is available in 3 standard lengths, 21mm and 25mm and 31 mm.
The SAF should be mounted on a vertical-motion vibration contra-angle handpiece with a 0.4mm amplitude and vertical vibration of 3000 - 5000 OPM (oscillations per minute). The file is attached to the handpiece via a polypropylene shank.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
root canals
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 SAF. In all instances the SAF functioned as intended and results observed were as expected.
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
Ko92933
510(k) SUMMARY
REDENT NOVA's SAF (Self Adjusting File)
JAN 1 4 2010
Submitter's Name, Address, Telephone Number, Contact Person: and Date Prepared
Hogan & Hartson
Phone: 202 637 5600 Facsimile: 202 637 5910
Contact Person: Jonathan S. Kahan
Date Prepared: December 14, 2009
Name of Device and Name/Address of Sponsor:
SAF (Self Adjusting File)
Redent Nova Ltd.
15 Hataasia street
P.O.B 4159
Ra'anana
.
43000, Israel
Common or Usual Name
SAF (Self Adjusting File)
Classification Name
| Name: | Dental Handpiece and accesories |
|---|---|
| Product code: | EFB |
| Classification regulation: | 872.4200 |
| Class: | I |
| Panel: | Dental |
1
Predicate Devices
ProTaper - Dentsply Tulsa Dental (510(k) exempt)
Quantec Series 2000 - Tyco Dental (K962031)
Profile 29 - Dentsply Tulsa Dental (K933582)
Intended Use / Indications for Use
The Self Adjusting file (SAF) is a mechanically operated endodontic file to be used for cleaning and shaping of root canals, as part of the procedure of root canal treatment.
Technological Characteristics
The ReDent SAF is an endodontic file that is indicated for use in root canal treatment for cleaning and shaping of the root canal. The file portion of the SAF consists of a metal lattice hollow cylinder and is constructed from medical grade nickel-titanium-alloy. The file's cylindrical lattice structure permits compression when inserted into the root canal followed by gradual radial expansion to fill the root canal profile. The file is surface treated by sandblasting, enabling it to file dentin from the canal's interior surface.
The SAF is available in 3 standard lengths, 21mm and 25mm and 31 mm.
The SAF should be mounted on a vertical-motion vibration contra-angle handpiece with a 0.4mm amplitude and vertical vibration of 3000 - 5000 OPM (oscillations per minute). The file is attached to the handpiece via a polypropylene shank.
Performance Data
Performance tests were carried out to evaluate the properties of the SAF. In all instances the SAF functioned as intended and results observed were as expected.
Substantial Equivalence
The SAF is substantially equivalent to the Quantec Series 2000 (manufactured by Tycom Dental), ProFile Series 29 (manufactured by Dentsply Tulsa Dental) and ProTaper (manufactured by Dentsply Tulsa Dental). The SAF has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the SAF and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrates that the SAF is as safe and effective as the Quantec Series 2000, ProFile Series 29 and the ProTaper. Thus, the SAF is substantially equivalent.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-6609 Silver Spring, MD 20993-0002
Redent Nova Limited C/O Mr. Jonathan S. Kahan Hogan & Hartson, L.L.P. Columbia Square 555 13th Street, Northwest Washington, DC 20004
JAN 1 4 2010
Re: K092933
Trade/Device Name: Self Adjusting File (SAF) Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: December 31, 2009 Received: December 31, 2009
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.
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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
for
Anthony D. Watson, BS, MS, MBA 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): K092933
Device Name:
The Self Adjusting File (SAF)
Indications for Use:
The Self Adjusting file (SAF) is a mechanically operated endodontic file to be used for cleaning and shaping of root canals, as part of the procedure of root canal treatment.
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)
RSBez DOS/or Dr.K.P.Mury (Acting)
(Division Sign-Off)
Page 1 of
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K092933.