SAF (SELF ADJUSTING FILE)

K092933 · Redent-Nova , Ltd. · EFB · Jan 14, 2010 · Dental

Device Facts

• Record ID: K092933
• Device Name: SAF (SELF ADJUSTING FILE)
• Applicant: Redent-Nova , Ltd.
• Product Code: EFB · Dental
• Decision Date: Jan 14, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended 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.

Device Story

SAF is a mechanically operated endodontic file used by dentists for root canal cleaning and shaping. Device consists of a hollow, cylindrical metal lattice made of nickel-titanium alloy; attached to a vertical-motion vibration contra-angle handpiece via a polypropylene shank. Operates at 3000-5000 oscillations per minute with 0.4mm amplitude. Lattice structure compresses upon insertion into canal and gradually expands to conform to the canal's internal profile; surface-treated via sandblasting to abrade dentin from canal walls. Used in clinical settings to facilitate root canal procedures.

Clinical Evidence

Bench testing only. Performance tests evaluated the properties of the SAF, confirming it functioned as intended with expected results.

Technological Characteristics

Endodontic file; medical grade nickel-titanium alloy lattice cylinder; polypropylene shank. Operates via vertical-motion vibration contra-angle handpiece (3000-5000 OPM, 0.4mm amplitude). Surface treated by sandblasting. Available in 21mm, 25mm, and 31mm lengths.

Indications for Use

Indicated for cleaning and shaping of root canals during root canal treatment.

Regulatory Classification

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.

Predicate Devices

• ProTaper - Dentsply Tulsa Dental (510(k) exempt)
• Quantec Series 2000 - Tyco Dental (K962031)
• Profile 29 - Dentsply Tulsa Dental (K933582)

Submission Summary (Full Text)

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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: [phone] 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 |

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### 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.

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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.

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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 [phone]. 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 [phone] or [phone] 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

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### 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.