(90 days)
No
The description focuses on the device's function as a light-curing unit and its substantial equivalence to a predicate device, with no mention of AI or ML.
No
The device is described as an "Activator for light-induced intraoral polymerization" of dental materials, which is a functional tool for a dental procedure rather than a device intended to treat or cure a disease or condition.
No.
The device is described as an "Ultraviolet Activator for Polymerization" intended to "polymerize (set) resinous dental pit and fissure sealants or restorative materials." This function is therapeutic/treatment-oriented, not diagnostic, as it does not gather or process data to identify a medical condition or disease.
No
The device description explicitly states it is a "Light-Curing Unit" and describes the transmission of light through a rod, indicating a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to polymerize dental materials intraorally using light. This is a direct treatment or procedure performed on the patient, not a test performed on a sample taken from the patient.
- Device Description: The device is classified as an "Ultraviolet Activator for Polymerization" and is a "Light-Curing Unit." This description aligns with a device used for a dental procedure, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device's function is to cure dental materials within the mouth, which is a therapeutic/restorative action, not a diagnostic one.
N/A
Intended Use / Indications for Use
Activator for light-induced intraoral polymerization of resinous dental pit and fissure sealants, restorative materials, bondings, or luting materials
Product codes
EBZ
Device Description
ELIPAR® TRILIGHT is classified as an Ultraviolet Activator for Polymerization (21 C.F.R. § 872.6070) because it is a device intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod. (Light-Curing Unit).
ELIPAR® TRILIGHT has the same intended use and is substantially equivalent to ESPE's already 510(k) cleared light-curing unit ELIPAR® (VISIO®). Actually, the ELIPAR® TRILIGHT light source is a further development of the ELIPAR® (VISIO®) light source to provide the patient and user with more comfortable handling and more favorable properties. The Euror® (Visio®) light source is well established and determined to be safe and effective.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraoral
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)
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
2/25/99
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS ll.
Submitter
| Name: | ESPE Dental AG |
|---|---|
| Street: | ESPE Platz |
| ZIP-Code, City: | D-82229 Seefeld |
| Federal State: | Bavaria |
| Country: | Germany |
| Contact: | Dr. Andreas Petermann, Regulatory Affairs |
| Phone: | 011-49-8152-700395 |
| Fax: | 011-49-8152-700869 |
| E-mail: | Andreas_Petermann@ESPE.de |
| Date: | 11/16/1998 |
Name of Device
| Proprietary Name: | ELIPAR® TRILIGHT |
|---|---|
| Classification Name: | Ultraviolet Activator for Polymerization |
| Common Name: | Light-Curing Unit |
Predicate Device
ELIPAR® (VISIO®) by ESPE .................(K803209)
Description for the Premarket Notification
ELIPAR® TRILIGHT is classified as an Ultraviolet Activator for Polymerization (21 C.F.R. § 872.6070) because it is a device intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod. (Light-Curing Unit).
ELIPAR® TRILIGHT has the same intended use and is substantially equivalent to ESPE's already 510(k) cleared light-curing unit ELIPAR® (VISIO®). Actually, the ELIPAR® TRILIGHT light source is a further development of the ELIPAR® (VISIO®) light source to provide the patient and user with more comfortable handling and more favorable properties. The Euror® (Visio®) light source is well established and determined to be safe and effective.
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 5 1999
Dr. Andreas Petermann Regulatory Affairs ESPE Dental AG ESPE Platz D-82229 Seefeld Bavaria, Germany
Re : K984247 Trade Name: Elipar® TriLight Regulatory Class: II Product Code: EBZ November 16, 1998 Dated: Received: November 27, 1998
Dear Dr. Petermann:
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 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). You may, therefore, market the device, subject to the general The general controls controls provisions of the Act. 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
2
Page 2 - Dr. Petermann
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
3
STATEMENT OF INDICATIONS FOR USE III.
Device Name:
ELIPAR® TRILIGHT
Indications for use:
Activator for light-induced intraoral polymerization of resinous dental pit and fissure sealants, restorative materials, bondings, or luting materials
1
Susan Runner
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 198844 510(k) Number
Prescription Use. (Per 21 CFR 801.109)
Presci i (Per 21 Crk out. 109)
510(k) Elipar® Trilight