VECTOR F SERIES HIGH-SPEED DENTAL HANDPIECES

K020113 · Vector Research & Development · EBF · May 17, 2002 · Dental

Device Facts

• Record ID: K020113
• Device Name: VECTOR F SERIES HIGH-SPEED DENTAL HANDPIECES
• Applicant: Vector Research & Development
• Product Code: EBF · Dental
• Decision Date: May 17, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is an air-powered dental handpiece for use by a trained professional in general dentistry.

Device Story

Air-powered dental handpiece; used by trained professionals in general dentistry. Device utilizes air pressure (30-35 psi) to drive a turbine for dental procedures. Features an autochuck mechanism with increased spring strength (8 lbs bur retention) to reduce risk of premature bur ejection. Design includes lightweight housing (2 oz) to reduce operator fatigue and softened knurling for improved tactile grip and easier cleaning/sterilization. Output is mechanical rotation for dental work. Sterilization via steam autoclave or chemical vapor.

Clinical Evidence

Bench testing only. Performance validation protocol confirmed the ability to repeatedly sterilize the device.

Technological Characteristics

Air-powered dental handpiece. Materials: Copper-tin bronze housing, nickel silver CDA alloy turbine housing, stainless steel turbine cap, chrome plating. Energy source: 30-35 psi air pressure. Weight: 2 oz. Sterilization: Steam autoclave or chemical vapor.

Indications for Use

Indicated for use by trained professionals in general dentistry for air-powered dental procedures.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Predicate Devices

• Star Dental 430 Series High Speed Handpiece (K982593)
• KaVO 625/634 Handpieces (K760929)

Submission Summary (Full Text)

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# MAY 1 7 2002

## EXHIBIT 2 Vector Research & Development 1909 70th Ave W, #C University Place, WA 98466 Tel [phone] Fax [phone] December 13, 2001 Contact: Brent Bigler

### 510(k) Summary of Safety and Effectiveness

- 1. Identification of the Device: Proprietary-Trade Name: "Vector F Series" High-speed Dental Handpieces. Classification Name: EFB Common/Usual Name: HANDPIECE, AIR-POWERED, DENTAL
- 2. Equivalent legally marketed device: Star Dental 430 Series High Speed Handpiece, K982593 and KaVO 625/634 Handpieces, K760929
- 3. Indications for Use (intended use) The device is an air-powered dental handpiece for use by a trained professional in general dentistry.
- 4. Description of the Device: The Vector F series handpiece shares virtually all specifications and design characteristics of the predicate devices. This was done intentionally by the designers and engineers. The only major design or engineering change is the strength of the autochuck mechanism. By increasing the spring strength we have created and even safer version of the KaVo 625CD. By increasing the bur retention strength form 6 lbs (as with the predicate device) to 8 lbs (Vector F series) we have been able to vastly reduce the odds of a bur prematurely ejecting for the handpiece. A few minor changes to the predicate device which do not affect the performance but we feel make the handpiece even safer are as follows: Reduction in the weight of the handpiece to 2 oz.. This reduces operator hand fatigue. Softened the knurling on the handle. This allows dirt, blood and saliva to be more easily removed from the body shell of the handpiece thus allowing better conformity to sterilization procedures. It also provides better tactile sense to the operator while wearing gloves.

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| Element of Comparison | StarDental 430 Series,<br>K982593; KaVO 625/634<br>Handpieces, K760929 | Vector F Series |
|-----------------------|------------------------------------------------------------------------|-------------------------|
| Intended Use | General dentistry by trained professional. | SAME |
| Materials: | Handpiece housing | Copper-tin Bronze |
| | Turbine Housing | Nickel silver CDA alloy |
| | Turbine housing cap | Stainless steel |
| | Plating | Chrome |
| Energy source | Air pressure, 30-32 psi | SAME, 30-35 psi |
| Sterilization | Steam autoclave or chemical vapor | SAME |

- 5. Safety and Effectiveness, comparison to predicate device:
- 6. Conclusion: In all respects, the Vector F Series High-speed Dental Handpieces are substantially equivalent to one or more air-powered dental handpieces currently marketed in the USA. The handpieces are constructed of identical materials and marketed in and Obstandards. The ability to repeatedly sterilize the devices has been confirmed through performance of a validation protocol.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing right, with flowing lines above them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 1 7 2002

Vector Research & Development C/O Mr. Daniel Kamm Kamm & Associates P. O. Box 7007 Deerfield, Illinois 60015

Re: K020113

Trade/Device Name: Vector F Series High-Speed Dental Handpieces Regulation Number: 872.4200 Regulation Name: Dental Handpiece Regulatory Class: I Product Code: EBF Dated: March 25, 2002 Received: March 26, 2002

Dear Mr. Kamm:

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 such 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.

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.

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#### Page 2 - Mr. Kamm

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone] . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Patricia Cucciniello

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# KO20113

#### j) Indications for Use

510(k) Number

Device Name: "Vector F Series" High-speed Dental Handpieces.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Over the Counter Use OR Prescription Use V (Per 21 CFR 801.109) seen (Division Sign-Off)
Division of Dental, (Division Sign-Off)
Division of Dental, Infection Control,
Division of Dental, Infection Deviceുപ്പുഴ (Division of Dental, Innection)
and General Hospital Devices (000) and GeNember –