(120 days)
No
The summary describes a dental restorative material with chemical and physical properties, not software or algorithms.
No
The device is a restorative material for dental fillings, not a therapeutic device. It is used to repair tooth structure, not to treat or cure a disease or condition in a therapeutic sense.
No
The provided text describes Ionolux as a restorative material used for fillings and core build-ups, which are treatment procedures, not diagnostic ones. There is no mention of it being used to identify or analyze diseases or conditions.
No
The device description clearly states it is a "resin-reinforced radiopaque light-curing glass-polyalkenoate restorative," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are for dental restorative procedures performed directly on a patient's teeth (fillings, core build-up, lining). These are clinical procedures, not laboratory tests performed on samples taken from the body.
- Device Description: The description of Ionolux as a "resin-reinforced radiopaque light-curing glass-polyalkenoate restorative" further confirms its nature as a material used in dental treatment, not for diagnostic testing.
- Lack of IVD Characteristics: The document does not mention any activities typical of IVDs, such as analyzing biological samples (blood, urine, tissue), detecting specific analytes, or providing diagnostic information about a patient's health status.
Therefore, Ionolux is a dental restorative material used for treatment, not a device used for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
lonolux is intended for the following applications:
-
- Restorations class III and V, especially cervical fillings and root caries
-
- Fillings on deciduous teeth
-
- Small class I fillings
-
- Temporary fillings
-
- Core build-up
-
- Lining
Product codes
EMA
Device Description
Ionolux is a resin-reinforced radiopaque light-curing glass-polyalkenoate restorative. The material has outstanding aesthetics, good handling properties and high chemical adhesion.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
GC Fuji II LC improved (K961584, GC America, Inc.)
Reference Device(s)
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
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.
0
K09 0817
510(k) SUMMARY
Contact: Manfred Th. Plaumann JUL 2 8 2009
Date prepared: March 24th, 2009
Trade or proprietary name: lonolux
Classification name: Cement, Dental (872.3275)
Predicate device:
GC Fuji II LC improved (K961584, GC America, Inc.)
Device description: Ionolux is a resin-reinforced radiopaque light-curing glass-polyalkenoate restorative. The material has outstanding aesthetics, good handling properties and high chemical adhesion.
Intended use:
lonolux is intended for the following applications:
-
- Restorations class III and V, especially cervical fillings and root caries
-
- Fillings on deciduous teeth
-
- Small class I fillings
-
- Temporary fillings
-
- Core build-up
-
- Lining
Technological characteristics: All of the components of Ionolux are found in the legally marketed device GC Fuji II LC improved (K961584, GC America, Inc.)
The prior use of all of the components of Ionolux in legally marketed devices supports our decision that additional testing for cytotoxicity and mutagenicity as well as additional blocompatibility studies with the final formulation are not necessary. We believe that the prio use of the components of lonolux in legally marketed devices and the performance data and results provided support the safety and effectiveness of lonolux for the intended use.
VOCO GmbH, March 24th, 2009
Manfred Th. Plaumann GMBH
Managing Boar
1
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of flowing lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ాళ్ల స
Mr. M. Th. Plaumann VOCO GmbH Anton- Flettner- Strasse 1-3 Cuxhaven Germany D-27472
JUL 23 2009
Re: K090817
Trade/Device Name: IONOLUX Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class; II Product Code: EMA Dated: July 9, 2009 Received: July 14, 2009
Dear Mr. Plaumann:
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 ffor 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 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. Plaumann
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 of the Act or any Federal statutes and regulations administered by other Federal agencies, You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Susan Runner
Susan Runner, D.D.S., M.A. Acting 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 Statement
510(k) Number: K090817
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
lonolux is intended for the following applications:
-
- Restorations class III and V, especially cervical fillings and root caries -
-
- Fillings on deciduous teeth
-
- Small class I fillings
-
- Temporary fillings
-
- Core build-up
-
- Lining
Prescription Use
OR
Over-The-Counter Use
(Please do not write Below this line-continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kerin Mily for MSR
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K090817