(26 days)
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Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The intended use describes a simple light-activated polymerization device.
No
The device is described as an "Activator for light-induced intraoral polymerization," which means it facilitates a chemical process to harden dental materials. It does not directly treat a disease or condition.
No
This device is an activator for light-induced polymerization of dental materials, which is a treatment function, not a diagnostic one.
No
The intended use describes a device that activates light-induced polymerization, which inherently requires a hardware component (a light source). The summary does not mention any software-only functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "light-induced intraoral polymerization of resin dental pit and fissure sealant, restorative materials, bonding , or luting materials." This describes a device used directly on the patient within the mouth to cure dental materials.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health.
This device's function is a therapeutic/procedural one performed in vivo (within the living body), not an in vitro (in glass/outside the body) diagnostic test.
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
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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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
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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)
Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 8 2004
Heraeus Kulzer GmbH & Company KG C/O Ms. Cheryl V. Zimmerman Manager, Quality Operations and Compliance Heraeus Kulzer, Incorporated 4315 South Lafayette Boulevard South Bend, Indiana 46614
Re: K042199
Trade/Device Names: Translux® Power Blue Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: August 12, 2004 Received: August 13, 2004
Dear Ms. Zimmerman:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaused the device is substantially equivalent (for the indications for referenced above and nove to legally marketed predicate devices marketed in interstate commerce use stated in the encreated to the Medical Device Amendments, or to devices that provision way 20, 1770, and cordance with the provisions of the Federal Food, Drug, and Cosmetic nuve boon roomseries and 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 thereone, manker the act include requirements for annual registration, listing of devices, good Controls provisions of a.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 If your de nee to such additional controls. Existing major regulations affecting your device can be finay of subject to bearn adam Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2 – Ms. Cheryl V. Zimmerman
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that 1 27x 5 tookine of our device complies with other requirements of the Act or that FDA hade a decemination administered by other Federal agencies. You must comply with CFFD Box 900 ally redular statutes and regularene, but not limited to: registration and listing (21 CFR Part 807); an the Act s requirements, morading, oractice requirements as set forth in the quality labeling (21 CFR Part 820); and if applicable, the electronic product radiation systems (QB) regarts (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 with anow you to ough finding of substantial equivalence of your device to a legally prematics nouried.com - The suits 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), please 11 you dosire specific ad rior of Compliance at (301) 594-4613. Additionally, for questions on the promotion connact the Office of Your device, please contact the Office of Compliance at (301) 594-4639. Also, and advertising of your avers, preference to premarket notification" (21CFR please note the regalation in. Other general information on your responsibilities under the Act may I all 007:77) you the Division of Small Manufacturers, International and Consumer Assistance at its oo obained in and the more (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
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
2
Page_1__of__1_
K04299 510(k) Number (if known):
Device Name: Translux® Power Blue
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)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K042199