(94 days)
3M ESPE AG, Elipar FreeLight, I.E. Demetrone I.
Not Found
No
The description details a device with a digital circuit controlling pre-programmed curing modes based on timing, which is standard digital control, not AI/ML. There is no mention of learning, adaptation, or complex pattern recognition.
No.
The device's intended use is to cure composite resins, which is a restorative rather than therapeutic function.
No
The device is used for polymerization of dental materials, which is a treatment function, not a diagnostic one.
No
The device description clearly outlines physical hardware components including a handpiece, battery charger, LED light "engine", printed circuit board, segmented display, and pushbutton.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "act as a polymerization source using visible light to cure composite resins." This describes a physical process applied to materials outside of the human body, specifically dental materials.
- Device Description: The description details a light-emitting device used for curing dental materials. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The intended use of the Power I.E.D is for the polymerization of visible light cured materials.
Intended Use for Power LED: The intended use of Power LED is to act as a polymerization source using visible light to cure composite resins.
Product codes
EBZ
Device Description
The Power LED Cordless Curing Light is a device used for the polymerization of dental materials using visible light. It consists of a cordless LED curing handpiece, a battery charger and a remote handpiece holder. The plastic molded handpiece will contain a detachable rechargeable battery pack, an LED light "engine". A printed circuit board with a digital circuit will be utilized to control four different curing modes. Each mode specifies LED timing and audible beep timing. A segmented display will depict the curing modes. A separate pushbutton will activate the light. The molded plastic battery charger will have a single well for charging the battery pack, and Indictor lights to indicate battery charge status.
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
Not Found
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)
3M ESPE AG, Elipar FreeLight, I.E. Demetrone I.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
FEB 27 2004
Image /page/0/Picture/2 description: The image is a logo for Dental Products of USA, Inc. The logo features the letters "DP" in a bold, stylized font, with the words "DENTAL PRODUCTS" above the letters and "OF USA" below. The full name of the company, "Dental Products of USA, Inc.", is printed in a smaller font below the logo. The website address, www.dentalproductsofusa.com, is also printed below the logo.
February 13, 2004
Section III 510(k) Summary of Safety and Effectiveness
Submitter:
Dental Products of USA, Inc. 1460 NW 107 Ave Suite G Miami, Florida 33172 Phone : (305) 640-9894 Facsimile: (305) 477-3206 Contact Person: George Echeverri
October 2,2003-February 13, 2004 Summary Prepared Date:
Device Name:
- Trade Name Bellini International I.
- Common Name Power LED II.
- Classification Name Ultraviolet activator for polymerization, per 21 CFR § 872.6070 ///
Device for Which Substantial Equivalence is Claimes:
- 3M ESPF. AG, Elipar FreeLight, I.E. Demertrone I.
Device Description:
The Power LED Cordless Curing Light is a device used for the polymerization of dental materials using visible light. It consists of a cordless LED curing handpiece, a battery charger and a remote handpiece holder. The plastic molded handpiece will contain a detachable rechargeable battery pack, an LED light "engine". A printed circuit board with a digital circuit will be utilized to control four different curing modes. Each mode specifies LED timing and audible beep timing. A segmented display will depict the curing modes. A separate pushbutton will activate the light. The molded plastic battery charger will have a single well for charging the battery pack, and Indictor lights to indicate battery charge status.
Intended Use of the Device:
The intended use of the Power I.E.D is for the polymerization of visible light cured materials.
Substantial Equivalence:
Power LED is substantial equivalence to other legally marketed devices in the United States. As Power LED functions in a manner similar to and is intended for the same use as the Elipar Freelight designed by ESPE AG
1460 NW 107 Ave Suite G . Miami, Florida6 33140 TEL (305) 640-9894 · FAX (305) 477-3206 · USA
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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 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.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 27 2004
Mr. George Echeverri Export Sales Director Dental Products of USA, Incorporated 1460 NW 107 Avenue, Suite G Miami, Florida 33172
Re: K033697
Trade/Device Name: Power LED Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: February 13, 2004 Received: February 17, 2004
Dear Mr. Echeverri:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(K) premained is substantially equivalent (for the indications for referenced above and have decemblic the devices marketed in interstate on merce use stated in the encrosure) to icgain manufacture proadinents, or to devices that proof to May 28, 1970, the chacinem unto of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Provincities (PMA). You may have been reclassified in accordance with the provisions on application (PMA). You may.
Act (Act) that do not require approval of a premarket approval application (PMA). The Act (Act) that do flor require approval or a premal controls provisions of the Act. The general therefore, market the device, subject to the general sense and registration, listing of devices, good controls provisions of the necessariat misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device Is classified (Sec above) into Elais) experience (1) in the claim (1) in thics can be may be subject to Such additions. Title 21, Parts 800 to 898. In addition, FDA may publish found in the Sourcements concerning your device in the Federal Register.
2
Page 2 -- Mr. George Echeverri
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 of that FDA has made a delemination that your ac-treal agencies. You must comply with any Federal statures and regulations administered by outs research agently of CFR Part 807);
all the Act's requirements, including, but not limited to seations and listing (2 all the Act s requirements, including, but not inner in as set forth in the quality
labeling (21 CFR Part 801); good manufacturer in the olostrania product radiation labeling (21 CFR Part 801), good manazona.net Franplicable, the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, 1050 systems (QS) regulation (21-531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k)
In a legal This letter will allow you to begin marketing your avince of your device of your device to a legally
premarket notification. The FDA finding of substantial equipalised the s premarket notification. The FDA midnig of substantal equive 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 If you desire specific auvice for your de rice on on and a many of concestions on the promotion
contact the Office of Compliance at (301) 594-4613. Additions of (201) 594-463 contact the Office of Compliance at (501) 591-1010 - 1910-1910 (1911) 594-4639. Also, 1910-199 and advertising of your device, prease corrence to premarket to premarket notification writing writing writing writing writing writing writing writing writing and please note the regulation entitical "Misonation on your responsibilities under the Act may Part 807.97) you the Division of Small Manufacturers, International and Consumer Assistance at its
be obtained from the Division of Small Manufacturers, International and Con be obtained from the D 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Oufs
Chiu S. Lin, PhD 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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Indications for Use
510(k) Number (if known): K033697
Device Name: Power LED
Indications for Use:
Intended Use for Power LED:
The intended use of Power LED is to act as a polymerization source using visible light to cure composite resins.
Prescription Use × (21 CFR Part 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Pumps
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K232697
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