(80 days)
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.
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.
The provided text describes a 510(k) submission for a dental light-curing unit called SAVEDENT BLUE. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria in the typical sense of a clinical trial for diagnostic performance.
Here's an analysis based on the provided text, addressing the requested points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The text does not explicitly state formal "acceptance criteria" in a quantitative, pre-defined manner often seen for diagnostic devices (e.g., sensitivity, specificity thresholds). Instead, the demonstration of equivalence is based on meeting or exceeding the performance of the predicate device for "cure depth."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Same or better performance in terms of cure depth for a given exposure time compared to the predicate device | "Comparative tests have demonstrated that SAVEDENTTM BLUE provides the same or better performance in terms of cure depth for a given exposure time as the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
The text does not specify the sample size used for the comparative tests or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Comparative tests."
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This information is not applicable or available from the provided text. The device is a light-curing unit, and its performance is measured by objective physical properties (cure depth) rather than a diagnostic interpretation requiring expert judgment.
4. Adjudication Method for the Test Set
This information is not applicable or available from the provided text, as the "ground truth" (cure depth) is based on physical measurement, not expert interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The SAVEDENT BLUE is a therapeutic device (light-curing unit).
6. If a Standalone Performance (Algorithm Only) Study Was Done
No, a standalone performance study in the context of an algorithm or AI is not applicable. The SAVEDENT BLUE is a hardware device (light-curing unit), not an algorithm. The "standalone performance" mentioned implicitly refers to its physical output parameters and ability to cure materials as designed.
7. The Type of Ground Truth Used
The ground truth used is the measured "cure depth" of the dental materials. This is an objective, quantitative physical property, not based on expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
This information is not applicable for this device. As a hardware light-curing unit, there is no "training set" in the context of machine learning or AI algorithms. The development involves engineering and testing, not algorithmic training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for this type of device.
{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
§ 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.