ADEC DENTAL UNIT, MODELS CENTURY PLUS & CASCADE, DCI DENTAL UNIT, MODEL SERIES III

K984609 · Lite Specialty Metal Works, Inc. · EIA · Feb 9, 1999 · Dental

Device Facts

• Record ID: K984609
• Device Name: ADEC DENTAL UNIT, MODELS CENTURY PLUS & CASCADE, DCI DENTAL UNIT, MODEL SERIES III
• Applicant: Lite Specialty Metal Works, Inc.
• Product Code: EIA · Dental
• Decision Date: Feb 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended Use

The LSM Dental Unit is intended to supply power to and serve as a base for other dental services. The Dental Operative Unit includes an automatic control system, a water control for hand pieces and syringes, a 3 way syringe, instrument holder, mounting, vacuum system, foot control and utility box.

Device Story

LSM Dental Unit serves as a base and power supply for dental instruments. Components include automatic control system, water control for handpieces/syringes, 3-way syringe, instrument holder, mounting, vacuum system, foot control, and utility box. Used in dental clinics by dental professionals to support various dental procedures. Device provides necessary utilities (power, water, vacuum) to operate handpieces and auxiliary dental tools, facilitating clinical dental care.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Electromechanical dental operative unit. Includes pneumatic/water control systems, vacuum system, and mechanical instrument mounting. Operates via foot control. No software or electronic processing described.

Indications for Use

Indicated for use as a base and power supply for dental instruments and services in a clinical dental setting.

Regulatory Classification

Identification

A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.

Predicate Devices

• ADEC Dental Unit, Models Century Plus (K984609)
• DCI Dental Unit (K984609)

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 9 1999

Mr. David R. Cole General Manager Lite Specialty Metal Works, Incorporated 20460 S.W. Avery Court Tualatin, Orlando 97062

Re : K984609 ADEC Dental Unit, Models Century Plus & Trade Name: Cascade, DCI Dental Unit Regulatory Class: I Product Code: EIA Dated: December 4, 1998 December 28, 1998 Received:

Dear Mr. Cole:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਖ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Cole

This letter will allow you to begin marketing your device as described in your 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 marice and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 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 the regaracion chercious (21 CFR 807.97). Other general information on your responsibilities under the Act may be Information on your vision of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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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LITE SPECIALTY

Image /page/2/Picture/2 description: The image shows a series of numbers in a bold, sans-serif font. The numbers are K984609 and they appear to be part of a larger document or label. The numbers are large and take up most of the frame, making them easily readable. The top right corner of the image says "PAGE 52".

Image /page/2/Picture/3 description: The image shows the logo for Lite Specialty Metal Works, Inc. The logo consists of the letters "LSM" stacked on top of each other inside of a black polygon on the left side of the image. The words "WORKS" are below the letters "LSM". On the right side of the image, the words "LITE SPECIALTY METAL WORKS, INC." are written in bold black letters.

510 (K) NUMBER: K984609

DEVICE NAME: LSM DENTAL UNIT

INDICATIONS FOR USE:

The LSM Dental Unit is intended to supply power to and serve as a base for other dental services. The Dental Operative Unit includes an automatic control system, a water control for hand pieces and syringes, a 3 way syringe, instrument holder, mounting, vacuum system, foot control and utility box.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Over-The-Counter-Use

Susan Runner

Prescription Use
(Per 21 CFR 801.109)

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number

Page 50 (Rev. 1)