(37 days)
No
The summary describes a light-curing unit for dental materials, a device that uses light energy for polymerization. There is no mention of AI, ML, image processing, or any data-driven decision-making or analysis within the device description or intended use. The device is presented as a further development of a previous light source, focusing on handling and properties, not computational capabilities.
No
This device is for polymerization of dental materials, not for treating a disease or condition.
No
Explanation: The device is a light-curing unit used for polymerization of dental materials, not for diagnosing diseases or conditions. Its function is to activate materials, not to detect abnormalities.
No
The device description explicitly states it is a "Light Curing Unit" and a "light source," indicating it is a hardware device that emits light for polymerization.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "light-induced intraoral polymerization of resin dental pit and fissure sealant, restorative materials, bonding , or luting materials." This describes a process performed within the patient's mouth to cure dental materials.
- Device Description: The device is described as an "Ultraviolet Activator for Polymerization" and a "light-curing unit." This aligns with a device used to activate materials in vivo.
- Anatomical Site: The anatomical site is "intraoral," meaning inside the mouth.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) outside the body, which is the defining characteristic of an in vitro diagnostic device.
Therefore, this device is a dental light-curing unit used for procedures performed directly on the patient, not an IVD.
N/A
Intended Use / Indications for Use
Activator for light-induced intraoral polymerization of resin dental pit and fissure sealant, restorative materials, bonding , or luting materials.
Product codes
EBZ
Device Description
Translux® Energy is a light-curing unit (Ultraviolet Activator for Polymerization) which is a further development of the Translux® EC light source to provide the patient and user with more comfortable handling and more favorable properties.
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
Not Found
Key Metrics
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
AUG 3 0 2001
Heraeus Kulzer, Inc. Translux® Energy 510(K) Submission
Summary of Safety and Effectiveness
Submitter:
| Company Name: | Heraeus Kulzer, Inc. |
|---|---|
| Address: | 4315 South Lafayette Blvd. |
| South Bend, Indiana 46614 | |
| Telephone No.: | 219-299-6662 |
| Fax No.: | 219-299-6616 |
| Date: | July 19, 2001 |
Name of Device
Date:
Classification Name: Ultraviolet activator for polymerization
Proprietary Name: Translux® Energy
Light-curing unit Common Name:
Predicate Device
Translux EC by Kulzer [K892456]
Description for the Premarket Notification
Translux Energy Light Curing Unit which is classified as an Ultraviolet Activator for Polymerization (21C.F.R. § 872.607).
Translux® Energy has the same intended use and is substantially equivalent to Kulzer's already 510(K)-cleared light-curing unit Translux® EC [K892456]. The Translux ® Energy is a further development of the Translux® EC light source to provide the patient and user with more comfortable handling and more favorable properties.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 0 2001
Ms. Cheryl V. Zimmerman Manager of Quality Operations & Complaince Heraeus Kulzer, Incorporated 4315 South Lafayette Boulevard South Bend, India 46614-2517
Re : K012341 Trade/Device Name: Translux® Enerqy Requlation Number: 872.6070 Regulatory Class: II Product Code: EBZ Dated: July 20, 2001 Received: July 24, 2001
Dear Ms. Zimmerman:
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 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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.
2
Page 2 — Ms. Zimmerman
concerning your device in the Eederal Register. Please note: concerning your device in enter in entification submission does chis response co your pro you might have under sections 531 not arrect any obrigation you miggs under the Electronic Chrough 542 of the Act 101 acress or other Federal laws or requlations.
This letter will allow you to begin marketing your device as a Inis receer will areas for market notification. The FDA described in your SIU(K) prematice of your device to a legally marketed predicate device results in a classification for your marketed predicate device rubals. In alle to proceed to the market.
If you desire specific advice for your device on our labeling II you desire bpccirie add additionally 809.10 for in regulation (21 chi rares), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on Compilance at (301) wertising of your device, please contact che Dfomotion and adversion (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). _ Other qeneral premation on your responsibilities under the Act may be obtained from the Division of Small Manufacturers obtained from the Bivibion on immand (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
K. Lilacrist
Timothy|A. Ulatowski Director Division of Dental, Infection Control
and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page_1__of__1_
510(k) Number (if known): 长创 234 |
Device Name: Translux® Energy
Indications for Use:
Activator for light-induced intraoral polymerization of resin dental pit and fissure sealant, restorative materials, bonding , or luting materials.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device evaluation (ODE)
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter Use | |
|---|---|
| (Optional Format 1-2-96) |
(Division Sign-Off) Pamela Scott for Susan Runner
Dental Infection Control
Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_1001233