(198 days)
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.
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 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.
The provided document is a 510(k) summary for a dental curing light, not an AI software or diagnostic device. Therefore, much of the requested information regarding AI-specific criteria (like expert adjudication, MRMC studies, training/test set details, and ground truth for AI models) is not applicable.
However, I can extract the relevant information regarding performance testing and acceptance criteria as described for this medical device.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance to ANSI/ADA Specification No. 48, Visible Light Curing Units (2004) | Conforms to the requirements. |
| Conformance to normalized standards for electromagnetic compatibility | Conforms to the requirements. |
| Conformance to normalized standards for safety characteristics of medical equipment | Conforms to the requirements. |
| Safely and effectively transmits blue light at wavelengths to initiate photopolymerization of light-cured dental restorative materials. | Wavelength of blue light transmitted is chosen to cure all common dental photoinitiators. |
| Sufficient intensity to initiate rapid polymerization. | Irradiant intensity is powerful enough to initiate rapid polymerization. |
| Intensity not so strong as to be a thermal hazard. | Irradiant intensity is not so strong as to be a thermal hazard. |
| Presence of UV and IR blocking filters. | UV and IR blocking filters are placed between the xenon arc lamp and the light guide. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of data used for algorithm validation as it's not an AI device. Instead, it refers to the physical device undergoing performance testing. The sample size for the device testing (e.g., how many units were tested) is not explicitly stated. The provenance of this physical testing data would be "in-house" or "laboratory testing" conducted by the manufacturer (Den-Mat Holdings, LLC).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a physical product (dental curing light), not an AI algorithm requiring expert consensus for ground truth. Its performance is validated against established industry standards and physical measurements.
4. Adjudication method for the test set
Not applicable. This is not an AI algorithm requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by conformance to recognized industry standards (ANSI/ADA Specification No. 48, Visible Light Curing Units (2004)) and normalized standards for electromagnetic compatibility and safety characteristics of medical equipment. This involves objective physical measurements and technical evaluations rather than human expert interpretation of data.
8. The sample size for the training set
Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI device that requires a training set.
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NOV 21 2008
Den-Mat® Holdings, LLC ISO 9001 Certified 2727 Skyway Drive Santa Maria, CA 93455 Phone: (805) 9 : 2-8491 FAX: (805) 922-6933
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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... ... ... ............................................................................................................................................................... ()wher
Den-Mat Holdings, LLC.
2727 Skyway Drive
Santa Maria, CA 93455 USA
Contact Person: Alan Matthews
Telephone: 805-922-8491
FAX: 805-922-6933
Date Prepared: 30 April 2008
- 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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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
§ 872.6070 Ultraviolet activator for polymerization.
(a)
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.(b)
Classification. Class II.