CROMAX HIGH SPEED TURBINE HANDPIECE

K041755 · J.R. Medical Technologies, Inc. · EFB · Oct 22, 2004 · Dental

Device Facts

• Record ID: K041755
• Device Name: CROMAX HIGH SPEED TURBINE HANDPIECE
• Applicant: J.R. Medical Technologies, Inc.
• Product Code: EFB · Dental
• Decision Date: Oct 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The device is an air-powered dental handpiece for use in general dentistry.

Device Story

Air-driven high-speed dental handpiece; utilizes turbine to power dental carbide burrs and diamond cutting instruments. Constructed of stainless steel; features water spray for cooling cutting burr; includes push-button chucking mechanism for ISO standard shanks. Used in dental clinics by dentists; provides mechanical cutting/abrading capability for tooth structure or restorative materials. Benefits patient by enabling precise dental cavity preparation and restorative procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Air-powered turbine handpiece; stainless steel construction; water spray cooling system; push-button chucking mechanism; ISO standard shank compatibility; sealed bearings; steam autoclave sterilization.

Indications for Use

Indicated for use in general dentistry as an air-powered dental handpiece for dental procedures.

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

• T1 Line Dental Handpieces (K972436)
• Rapidd Highspeed Dental Handpiece (K003518)

Submission Summary (Full Text)

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# OCT 2 2 2004

### Summary

### 510(k) Summary of safety and effectiveness

Date: 6/17/2004

| Submission By: | JR Medical Technologies, Inc.<br>6650 Cottage Hill Road, Suite 307<br>Mobile, AL 36695 |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Manufactured by: | Shanghai Foshion Medical Instrument Co.,<br>Ltd.<br>Buld.15, NO. 1515 Yuandong Rd(N)<br>Fengxian District,<br>Shanghai 201401<br>China |
| Contact: | John Rhim<br>251-895-0303<br>251-479-7777 Fax<br>[e-mail] |
| Device Name: | CROMAX turbine handpiece |
| Common Name: | Handpiece, air-powered, dental |
| Classification Name: | Dental handpiece |
| Device Class: | Class I |
| Product Code: | 76 EFB |
| Code of Federal Regulations: | 21 CFR § 872.4200 |
| Indications for Use: | The device is an air-powered dental<br>handpiece for use in general dentistry. |
| Predicate Device Name: | T1 Line Dental Handpieces, K972436 and<br>Rapidd Highspeed Dental Handpiece<br>K003518 |

#### Description of Device:

The CROMAX Turbine Handpiece is an air-driven high-speed dental handpiece. It has an airdriven turbine with appropriate power and speed for use with dental carbide burrs and diamond cutting instruments. Construction is stainless steel for corrosion resistance. It has water spray for cooling of the cutting burr. One model has push-button chucking mechanism to grip cutting instrument with ISO standard shanks.

The CROMAX Turbine Handpiece may be sterilized by the steam autoclave method. The bearing are sealed.

Technically supported and adopted key components of rotor and ball bearing from § •››Air, Switzerland. Foshion produced CROMAX turbine handpiece and powered by Bien -- ir.

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#### Substantially Equivalence - Safety and Effectiveness:

CROMAX Turbine Handpiece is substantially equivalent to one or are air-powered dental handpieces currently marketed in the USA. The handpiece is constructed of the same specifications as the predicate device to ensure biocompatibility. The handpiece conforms to applicable ISO standards.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three overlapping lines forming a wing-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 2 2004

J.R. Medical Technologies, Incorporated C/O Mr. J. Harvey Knauss Contract Consultant Delphi Consulting Group 11874 South Evelyn Circle Houston, Texas 77071-3404

Re: K041755

Trade/Device Name: CROMAX Turbine Handpiece Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: October 14, 2004 Received: October 18, 2004

Dear Mr. Knauss:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becamined 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 Interstate commerce prior to fray are been reclassified in accordance with the provisions of Amendinens, or to active and Cosmetic Act (Act) that do not require approval of a premarket the Federal 1 600; Drag, Drag, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of the stration, 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 such additional controls. Existing major regulations affecting (1 Wry, It may be basyon 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. Knauss

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA S Issualled of a sacceantles with other requirements mean that FDA has made a decemination that your and ministered by other Federal agencies.
of the Act or any Federal statutes and regulations and real that and the registratio of the Act of any rederal statutes and registements, including, but not limited to: registration
You must comply with all the Act's requirements, including and manufacturing You must comply with an the Act 3 required interest 801); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gract 820'; and i and listing (21 CFR Part 807), laboring (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 821, 542 of the Ar requirements as set form in the quality systems (Sections 531-542 of the Act);
applicable, the electronic product radiation 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 anow you to begin maticeming your alence of your device to an premarket nothleation. The I Dr Intellig of obserm.
Iegally 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 advice for your de recognize . Also, please note the regulation prease contact the Other of Other of Comphariet notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Illay obtain other general micromational and Consumer Assistance at its toll-free Division of Bircason or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Qurs

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

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## Indications for Use

510(k) Number

Device Name: CROMAX Turbine Handpiece

Indications for Use: The device is an air-powered dental handpiece for use in general dentistry.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Sumana

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Continess Control Dental Devices Division of Anesthesionogy,

510(k) Number: