APOLLO 9500

K974369 · Ion Laser Technology · EBZ · Jan 6, 1998 · Dental

Device Facts

• Record ID: K974369
• Device Name: APOLLO 9500
• Applicant: Ion Laser Technology
• Product Code: EBZ · Dental
• Decision Date: Jan 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Source of illumination for curing dental restorative materials; and, Source of illumination for tooth whitening activities performed in dentistry.

Device Story

Apollo 9500 functions as a dental illumination source; provides light energy for curing light-activated restorative materials and facilitating tooth whitening procedures. Operated by dental professionals in clinical environments. Device delivers specific wavelengths of light to target materials or teeth; enables polymerization of resins or activation of whitening agents. Output allows clinicians to perform restorative and cosmetic dental procedures efficiently. Benefits include improved material hardening and accelerated whitening outcomes.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Illumination source for dental applications. Device utilizes light energy for curing and whitening. Specific materials, dimensions, and connectivity details not provided in the submission document.

Indications for Use

Indicated for use as an illumination source for curing dental restorative materials and for tooth whitening procedures in a dental clinical setting.

Regulatory Classification

Identification

An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.

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

Mr. Raymond Kemple
Vice President Quality Assurance & Regulatory Affairs
Ion Laser Technology
3828 South Main Street
Salt Lake City, Utah 84116
JAN - 6 1998

Re: K974369
Trade Name: Apollo 9500
Regulatory Class: II
Product Code: EBZ
Dated: November 14, 1997
Received: November 20, 1997

Dear Mr. Kemple:

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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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

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Page 2 - Mr. Kemple

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.

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 [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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510(k) Number (if known): K974369

Device Name: Apollo 9500

Indications for Use:

Source of illumination for curing dental restorative materials; and,

Source of illumination for tooth whitening activities performed in dentistry.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K974369

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐
(Optional Format 1-2-96)