(35 days)
K-952333, K-981948, K-982615, K-982318, K-980792, K-980793
K-952333, K-981948, K-982615, K-982318, K-980792, K-980793
No
The summary describes a light-based device for curing and whitening, with no mention of AI, ML, image processing, or data-driven performance metrics.
No
The device is used for curing dental restorative materials and assisting in the whitening process, which are functional procedures rather than therapeutic interventions aimed at treating a disease or condition.
No
The device is described as a light source for curing dental materials and assisting in teeth whitening. Its function is to provide illumination, not to diagnose medical conditions or analyze data to determine the presence or nature of a disease.
No
The device description explicitly states it is a "high pressure mercury light source filtered and transmitted through an optical fiber," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses are for curing dental restorative materials and assisting in teeth whitening. These are procedures performed directly on the patient's teeth, not on samples taken from the body for diagnostic purposes.
- Device Description: The device is a light source used for curing and whitening. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device's function is based on the interaction of light with dental materials and teeth.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
This device is intended for use:
-
- As a source of illumination for curing dental restorative materials,
-
- Assisting in the whitening process in a dental office.
Product codes
EBF, EEG, EBZ
Device Description
The RapiCure 2000 is a high pressure mercury light source filtered and transmitted through an optical fiber for the curing of composite resins, as an aid in the whitening of teeth, and for other dental purposes. 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)
K-952333, K-981948, K-982615, K-982318, K-980792, K-980793
Reference Device(s)
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
NOV - 1 1999
Image /page/0/Picture/1 description: The image shows a sequence of digits and a letter. The sequence starts with the letter 'K', followed by the numbers '993223'. The characters are bold and black against a white background. The font appears to be rounded and sans-serif.
- XII. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Separate Page)
- A. Submitter: Robert McClane, Mediphotonix, LC, 484 H Street, Salt Lake City, UT 84103, phone: 801-363-4418.
- I. Classification: Class II and Class I.
- II. Common or usual name: Curing and whitening light.
- III. Proprietary Name: RapiCure 2000™ Curing and Whitening Light
- IV. Registration No .: In process
- V. Classification Name: Tooth-shade resin (Accessory) EBF, Class II; and, Heat source for bleaching teeth EEG, Class I.
- VI. Performance standards: None established under section 514.
- VII. Description: The RapiCure 2000 is a high pressure mercury light source filtered and transmitted through an optical fiber for the curing of composite resins, as an aid in the whitening of teeth, and for other dental purposes. 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: RapiCure 2000™ Curing and Whitening Light is substantially equivalent to the Plasma Arc Curing system cleared by American Dental Technologies in K-952333, to the Apollo 95 curing and whitening system cleared in K-981948 by Dental/Medical Diagnostic Systems, Inc., 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.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings and two curved lines representing its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 1 1999
Mr. Robert McClane Official Correspondent Mediphotonix, LC 484 H Street Salt Lake City, UT 84103
K993223 Re :
Rapicure 2000 (Curing and Whitening Light) Trade Name: Regulatory Class: II Product Code: EBZ Dated: September 21, 1999 Received: September 27, 1999
Dear Mr. McClane:
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 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 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 not affect any
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Page 2 - Mr. McClane
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
thy A. Ulatowski Tir Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
IX. Indications for Use: [Separate Page]
510(k) Number: NA
Device Name: RapiCure 2000 ™ Curing and Whitening Light.
This device is intended for use:
-
- As a source of illumination for curing dental restorative materials,
-
- Assisting in the whitening process in a dental office.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21CFR 801.109)
or
Over-The-Counter Use_
(Optional Format 1-2-96)
Susan Punner
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _