OPTIMA PLUS E DENTAL CHAIR; A DENTAL CHAIR; EXCEL CHAIR

K971063 · King Dental Corp. · KLC · Jun 3, 1997 · Dental

Device Facts

• Record ID: K971063
• Device Name: OPTIMA PLUS E DENTAL CHAIR; A DENTAL CHAIR; EXCEL CHAIR
• Applicant: King Dental Corp.
• Product Code: KLC · Dental
• Decision Date: Jun 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6250
• Device Class: Class 1

Intended Use

THESE DENTAL CHAIRS ARE USED SO THAT THE PATIENTS AT THE DENTIST OFFICE MAY SIT ON THEM WHILE THE DENTIST IS PERFORMING ROUTINE DENTAL EXAMS. THESE CHAIRS DO NOT HAVE ANY INSTRUMENTS THAT MAY BE USED ON THE PATIENT.

Device Story

Optima Plus "A", Optima Plus "E", and Excel dental chairs; patient support platforms for use during routine dental examinations. Device provides seating for patients; contains no integrated dental instruments. Operated by dental professionals in clinical settings. Benefit: provides stable, adjustable patient positioning to facilitate dental exams.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Dental chair assembly; mechanical patient support platform. No electronic, software, or algorithmic components. No specific materials or standards cited.

Indications for Use

Indicated for patients in a dental office setting during routine dental examinations.

Regulatory Classification

Identification

A dental chair and accessories is a device, usually AC-powered, in which a patient sits. The device is intended to properly position a patient to perform dental procedures. A dental operative unit may be attached.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN - 3 1997

Mr. Jame F. Briggs
King Dental Corporation
7104 N.W. 72 Avenue
Miami, Florida 33166

Re: K971063
Trade Name: Optima Plus "E" Dental Chair, "A" Dental Chair, Excel Chair
Regulatory Class: I
Product Code: KLC
Dated: March 12, 1997
Received: March 24, 1997

Dear Mr. Briggs:

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 Regulations, Title 21, Parts 800 to 895. A 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 regulation 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Briggs

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 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone].

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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Page ___ of ___

510(k) Number (if known): K971063

Device Name: OPTIMA PLUS "A" DENTAL CHAIR, OPTIMA PLUS "E" DENTAL CHAIR, EXCEL DENTAL CHAIR

Indications For Use:

THESE DENTAL CHAIRS ARE USED SO THAT THE PATIENTS AT THE DENTIST OFFICE MAY SIT ON THEM WHILE THE DENTIST IS PERFORMING ROUTINE DENTAL EXAMS. THESE CHAIRS DO NOT HAVE ANY INSTRUMENTS THAT MAY BE USED ON THE PATIENT.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Bunner

(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices

510(k) Number K971063

Prescription Use ☑ (Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

(Optional Format 1-2-96)