SAPPHIRE PLASMA ARC DENTAL CURING LIGHT

K081287 · Den-Mat Holdings, LLC · EBZ · Nov 21, 2008 · Dental

Device Facts

• Record ID: K081287
• Device Name: SAPPHIRE PLASMA ARC DENTAL CURING LIGHT
• Applicant: Den-Mat Holdings, LLC
• Product Code: EBZ · Dental
• Decision Date: Nov 21, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sapphire PAC Light is a source of illumination for curing dental restorative materials and is a source of illumination for tooth whitening activities performed in dentistry.

Device Story

Sapphire Supreme PAC Dental Curing Light is a xenon plasma arc lamp system used in dental clinics. Device consists of a base unit containing the lamp, power supply, and filters, connected via a fiber-optic bundle to a handpiece with a removable curing tip. Clinicians operate the device to emit blue light of specific wavelengths and intensity to initiate photopolymerization of dental restorative materials or to facilitate tooth whitening. Filters block UV and IR wavelengths to prevent thermal hazards. Exposure time is controlled via interfaces on the base unit or the handpiece. Removable tips allow for sanitization between patients. The device provides rapid curing of dental materials, improving clinical efficiency and restorative outcomes.

Clinical Evidence

Bench testing only. The device was evaluated for compliance with ANSI/ADA Specification No. 48 (Visible Light Curing Units, 2004) and normalized standards for electromagnetic compatibility and safety characteristics of medical equipment.

Technological Characteristics

Xenon plasma arc lamp light source; fiber-optic bundle transmission; UV and IR blocking filters; removable curing tips; base unit and handpiece interface; manual exposure timing controls. Complies with ANSI/ADA Specification No. 48.

Indications for Use

Indicated for use in dentistry as a light source for the photopolymerization of light-cured dental restorative materials and for tooth whitening procedures.

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.

Predicate Devices

• PlasmaCure BXe (K033795)

Submission Summary (Full Text)

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K081287

NOV 21 2008

Den-Mat® Holdings, LLC ISO 9001 Certified 2727 Skyway Drive Santa Maria, CA 93455 Phone: (805) 9 : 2-8491 FAX: [phone]

510(k) Summary Statement for the Sapphire® Supreme Plasma Arc Dental Curing Light

The following Summary has been prepared pursuant to requirements listed in 21CFR 807.92(a)

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Den-Mat Holdings, LLC.

2727 Skyway Drive

Santa Maria, CA 93455 USA

Contact Person: Alan Matthews

Telephone: [phone]

FAX: [phone]

Date Prepared: 30 April 2008

2. Device Name

Proprietary Name: Sapphire@ Supreme PAC Dental Curing Light

Common Name: dental curing light

Classification Name: ultraviolet activator for polymerization (21 CFR 872,6070),

product classification code EBZ

יי Predicate Device

PlasmaCure BXe (K033795) eeLe Laboratories, LLC, Bohemia, NY 11716 USA

中 Device Description

The Sapphire Supreme Plasma Arc Dental Curing Light consists of a xenon plasma arc light source (lamp), power supply with user interface controls, and a light guide with a priol-type handpiece with user interface compls. The light from the xenon arc lamp is transmitted through optical litters that largely eliminate unnecessary ultraviolet (UV), visible, and infrared (IR) wavelengths into the proximal end of the light guide, where it is conducted

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through a fiber-optic bundle and focused through a removable tip at the light guide. Controls on both the light source and the handpiece activate the lamp and time of exposure.

The Sapphire PAC Light safely and effectively transmits blue light at wavelengths and with sufficient intensity to initiate photopolymerization of light-cured dental restorative naterials. Ultraviolet (UV) and infrared (IR) blocking filters are placed between the xenon arc lamp and the light guide. The wavelength of the blue light transmitted by the device is chosen to cure all common dental photoinitiators; its irradiant intensity is powerful enough to initiate rapid polymerization while not so strong as to be a thermal hazard.

## 5. Intended Use

The Sapphire PAC Light is a source of illumination for curing dental restorative materials and is a source of illumination for tooth whitening activities performed in dentistry.

#### Technological Characteristics and Substantial Equivalence 6.

The technological and operational principles of both the proposed and predicate devices are identical. Both transmit visible blue light at wave lengths known to initiate photopolymerization of common dental photoinitiators. Both devices use xenon are lamps as the source of illumination; however, the predicate device' handpiece houses the lamp and filter assembly whereas the proposed device 'lamp and filter assembly is housed in a base unit and uses a fiber-optic bundle to transmit light to the light-cured restorative material. Both devices employ removable curing tips to focus radiant energy and permit unit sanitization between patients. Both devices' time of exposure can be controlled from the handpiece; the p: oposed device may also be controls on the base unit.

## 7. Performance Testing

The proposed device has been found to conform to the requirements in ANSI/ADA Specification No. 48, Visible Light Curing Units (2004), and to normalized standards for clectromagnetic compatibility and saley characteristics of medical equipment.

#### Conclusion

Testing confirms that the proposed Sapphire Supreme PAC Light is safe and effective for its intended use as a dental curing light and as a source of illumination for dental tooth-whitening activities., The subject device is substantially equivalent to the predicate device in regard to its intended use, characteristics, performance, labeling, and safety features.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Alan Matthews Quality Assurance Manager Den-Mat Holdings, L.L.C. 2727 Skyway Drive Santa Maria, California 93455

NOV 21 2008

Re: K081287

Trade/Device Name: Sapphire Plasma Arc (PAC) Dental Curing Light Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: October 30, 2008 Received: November 14, 2008

Dear Mr. Matthews:

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.

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Page 2 - Mr. Matthews

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, 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Survcillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act 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.gov/cdrh/industry/support/index.html.

Sincerely vours.

Clars

Chiu S. Lin. Ph. D Division 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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# SECTION 5. Indications for use

510(k) Number (if known): K081287

Device Name: Sapphire Plasma Arc (PAC) Dental Curing Light

The Sapphire PAC Light is a source of illumination for curing dental restorative materials and is a source of illumination for tooth whitening activities performed in dentistry.

Prescription Use _x__

and/or

OTC Use ________

(Per 21 CFR 801 subpart D)

(Per 21 CFR 801 subpart C)

Susan Cooper

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

510(k) Number: K081252