(47 days)
This device is intended for use in:
- Source of illumination for curing dental restorative materials,
- Assisting in the whitening process in dental office.
The Easy-Cure™ Curing and Whitening Light is comprised of a high-intensity light source filtered and transmitted through an optical fiber for the curing of composite resins and as an aid in the whitening of teeth. The device emits filtered light in the range from 400 to 500 nm. It accepts voltages from 100-230 VAC.
This looks like a 510(k) submission for a dental curing and whitening light, which is a physical device, not an AI/ML powered software. Therefore, the requested information about acceptance criteria and clinical study results, including details like sample size, ground truth, expert qualifications, and MRMC studies, are not applicable in the context of this specific document.
The document primarily focuses on establishing "substantial equivalence" to existing predicate devices based on its intended use, design, and performance characteristics (like light spectrum and voltage). It does not present a study with performance metrics in the way one would for an AI/ML device.
Here's why the requested information isn't present in this document:
- Acceptance Criteria & Device Performance: The document states "Performance standards: None established under section 514." This means there aren't specific universally mandated performance metrics that the device must meet in the same way an AI algorithm might have. Substantial equivalence is determined by comparing its specifications and intended use to existing, legally marketed devices.
- Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth, Training Set: These are all concepts related to the validation of software algorithms, particularly AI/ML models, where performance is measured against a "ground truth" established by experts on a dataset. A dental light curing device doesn't operate in this manner. Its "performance" is typically assessed through engineering specifications (light intensity, wavelength, safety features) and comparison to predicate devices, rather than statistical analysis on a clinical dataset in the AI/ML sense.
Instead of the requested table, the document achieves its goal by demonstrating:
- Description: The device emits filtered light in the range of 400 to 500 nm and accepts 100-230 VAC.
- Indications for Use: Curing dental restorative materials and assisting in tooth whitening.
- Substantial Equivalence: It lists several predicate devices (e.g., Plasma Arc Curing system, Ardent Radiance Curing Light, Spectrum 800 Curing Unit) that it claims to be substantially equivalent to, based on similar technology, indications, and safety.
In summary, this document is for a traditional medical device (a light source), not an AI/ML software. Therefore, the questions posed about AI/ML device validation are not applicable.
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XII, 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Separate Page)
A. Submitter: Alan A. Creamer, President, ICS of North American, Inc., 10054 Mesa Ridge Ct. San Diego, CA 92121
I. Classification: Class II and Class I.
II. Common or usual name: Curing and whitening light.
III. Proprietary Name: Easy-Cure™ Curing and Whitening Light
IV. Registration No .: 61073
V. Classification Name: Tooth-shade resin (Accessory) and, Heat source for bleaching teeth, Class II and Class I.
VI. Performance standards: None established under section 514.
VII. Description: The Easy-Cure™ Curing and Whitening Light is comprised of a high-intensity light source filtered and transmitted through an optical fiber for the curing of composite resins and as an aid in the whitening of teeth. The device emits filtered light in the range from 400 to 500 nm. It accepts voltages from 100-230 VAC.
VIII. Labels and Labeling: Labels and Instructions for Use are provided. Competitive labels and labeling are provided and the products are compared.
IX. Indications for Use: source of illumination for curing dental restorative materials, and for tooth whitening activities.
X. Substantial Equivalence: Easy-Cure™ Curing and Whitening Light is substantially equivalent to the Plasma Arc Curing system cleared by American Dental Technologies in K-952333, to the Ardent Radiance Curing Light cleared by Air Techniques, Inc., in K-982615, to the Spectrum 800 Curing Unit, cleared by Dentsply in K-982318, the CU-100A Light Cure Unit cleared in K-980792, the O-Luxpro V/Q-Luxpro II Light Unit cleared in K-980793 and several other curing lights cleared under code EBF as accessories to composite materials classified as "tooth-shade resin and described in CFR 872.3690.
The "510(k) Substantial Equivalence Decision-making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed.
End of Summary
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We believe we have provided sufficient information to allow the determination of substantial equivalence for this device. We could not find any specific guidance documents on the subject but have complied with the terms of the general guidance documents for preparation of premarket notifications-510(k)s. If additional information or explanation is needed, please call me at 619-558-9203 or fax me at 619-558-1243. Alternately, you may contact Dr. H. N. Dunning at 301-229-2138, 8309 Bryant Dr., Bethesda, MD 20817, for a local response.
Sincerely yours
Alan A. Creamer
President
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 30 1999
Mr. Alan A. Creamer President ICS of North America, Incorporated 10054 Mesa Ridge Court Suite 104-106 San Diego, California 92037
K992357 Re : EASY-CURE (CURING AND WHITENING LIGHT) Trade Name: Requlatory Class: II Product Code: EBZ Dated: July 14, 1999 Received: July 14, 1999
Dear Mr. Creamer:
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 aqainst 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
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Page 2 - Mr. Creamer
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 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timb thy 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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IX. Indications for Use: {Separate Page}
510(k) Number: NA
Device Name: Easy-Cure™ Curing and Whitening Light.
This device is intended for use in:
-
- Source of illumination for curing dental restorative materials,
-
- Assisting in the whitening process in dental office.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suxar Tuna
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices K992335 510(k) Number
Prescription Use_ (Per 21 CFR 801.109)
or
Over-The-Counter Use_
(Optional Format 1-2-96)
§ 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.