(80 days)
Not Found
No
The description focuses on the light source and its power/timing, with no mention of AI/ML terms or functionalities.
No
The device is used to cure dental materials, not to treat a disease or condition in a patient.
No
Explanation: The device is a curing light used to activate light-cured dental materials, not to diagnose medical conditions. Its purpose is to harden or set materials, not to identify diseases or perform diagnostic assessments.
No
The device description explicitly states it is a "LED based curing light" and a "lightweight handheld unit," indicating it is a physical hardware device that emits light.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "Light source for the activation of light cured resin polymers and glass ionomer materials used in dentistry". This describes a device used to process materials outside the body, not to diagnose a condition based on in vitro examination of specimens.
- Device Description: The description reinforces this by stating it's a "LED based curing light intended to polymerise and therefore cure, harden or set resin or glass ionomer based dental materials". Again, this is about material processing, not diagnostic testing.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is a dental curing light, which is a therapeutic or restorative device used in the practice of dentistry.
N/A
Intended Use / Indications for Use
Light source for the activation of light cured resin polymers and glass ionomer materials used in dentistry as pit and fissure sealants, restorative materials, and bonding materials.
Product codes (comma separated list FDA assigned to the subject device)
EBZ
Device Description
SAVEDENT The BLUE is an LED based curing light intended to polymerise and therefore cure, harden or set resin or glass ionomer based dental materials used for restorative, sealing or cementing procedures. It is a lightweight handheld unit delivering up to 1000mW/cm2 for set times between 10 and 40 seconds. It has the same intended purpose, uses the same technology as and offers the same significant output parameters (power density and wavelength) as the predicate device and is therefore substantially equivalent to it.
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)
Comparative tests have demonstrated that SAVEDENTIAN BLUE provides the same or better performance in terms of cure depth for a given exposure time as the predicate device.
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.
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
Denfotex Light Systems Ltd
Image /page/0/Picture/1 description: The image is a black and white circular logo with the word "Denfotex" written in white letters across the center. The background of the circle is black. The text is in a simple, sans-serif font and is horizontally centered within the circle.
NOV - 1 2004
Kouzing
Unit 15, Belleknowes Ind.Est., Inverkeithing, Fife KY11 1HZ Tel. 01383411555 Fax 01383411666
510(k) SUMMARY
Submitted by Dr John Colles, Innovations Director Contact Dr John Colles. Telephone as above or Mobile no. 07786518919 Date: 15-04-04
Name of Device.
| Proprietary Name: | SAVEDENTTM BLUE |
|---|---|
| Classification Name: | Ultraviolet activator for polymerisation |
| Common Name: | Light Curing Unit. |
Classification ... ... ............................. Ultraviolet activator under 872.3260 (class 2) Dental panel, product code EBZ.
Predicate Device.
Elipar™ Freelight from 3M ESPE ......... K011154 (Product Code: EBZ).
Description for the Premarket notification.
SAVEDENT The BLUE is a LED based curing light intended to polymerise and therefore cure, harden or set resin or glass ionomer based dental materials used for restorative, sealing or cementing procedures. It is a lightweight handheld unit delivering up to 1000mW/cm2 for set times between 10 and 40 seconds. It has the same intended purpose, uses the same technology as and offers the same significant output parameters (power density and wavelength) as the predicate device and is therefore substantially equivalent to it.
Comparative tests have demonstrated that SAVEDENTIAN BLUE provides the same or better performance in terms of cure depth for a given exposure time as the predicate device.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a stylized symbol that resembles a person with their arms outstretched.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 1 2004
Denfotex Light Systems Limited C/O Mr. William J. Sammons Responsible Third Party Official Underwriters Laboratories, Incorporated 12 Laboratory Drive P.O. Box 13995 Research Triangle Park, North Carolina 27709-3995
Re: K042196
Trade/Device Name: SAVEDENT BLUE Regulation Number: 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: October 19, 2004 Received: October 19, 2004
Dear Mr. Sammons:
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.
2
Page 2 – Mr. Sammons
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 modifine and regulations and regulations administered by other Federal agencies. or mo receir any a vith 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 and ifouns (2) - set forth in the quality systems (QS) regulation (21 CFR Part 820); and if roquicable, 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) I mis letter wification. The FDA finding of substantial equivalence of your device to a promarket notificated 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), n you accures of the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may overn of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Carls
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications For Use
K042196 510(k) Number (if known):
Device Name: _SAVEDENT BLUE
Indications For Use:
Light source for the activation of light cured resin polymers and glass ionomer materials used in dentistry as pit and fissure sealants, restorative materials, and bonding materials.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control, De
510(k) Number: K042196