(47 days)
K-952333, K-982615, K-982318, K-980792, K-980793
Not Found
No
The device description focuses on the light source and optical fiber for curing and whitening, with no mention of AI, ML, image processing, or data-driven performance metrics.
No
The device is described as a light source for curing dental restorative materials and assisting in teeth whitening. Neither of these uses is considered a therapeutic treatment for a disease or medical condition. Curing materials is a restorative procedure, and teeth whitening is a cosmetic procedure.
No
The device description indicates its functions are for curing dental restorative materials and assisting in the whitening process, which are treatment or procedural aids, not diagnostic functions.
No
The device description explicitly states it is comprised of a high-intensity light source, optical fiber, and accepts electrical voltages, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body ("in vitro").
- Device Function: The Easy-Cure™ Curing and Whitening Light is used directly on the patient's teeth to cure dental materials and assist in whitening. It does not analyze any specimens taken from the body.
- Intended Use: The intended uses clearly describe procedures performed on the patient, not laboratory testing of samples.
Therefore, based on the provided information, this device falls under the category of a dental device used for treatment and procedures performed directly on the patient, not an IVD.
N/A
Intended Use / Indications for Use
source of illumination for curing dental restorative materials, and for tooth whitening activities.
This device is intended for use in:
-
- Source of illumination for curing dental restorative materials,
-
- Assisting in the whitening process in dental office.
Product codes (comma separated list FDA assigned to the subject device)
EBZ
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental office.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K-952333, K-982615, K-982318, K-980792, K-980793
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
3
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)