IONOLUX by VOCO GMBH | FDA 510(k) Summary

Ionolux is a resin-reinforced radiopaque light-curing glass-polyalkenoate restorative. The material has outstanding aesthetics, good handling properties and high chemical adhesion.

AI/ML Overview

This document describes a 510(k) premarket notification for a dental cement called Ionolux. As such, it does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria.

510(k) summaries are primarily focused on demonstrating substantial equivalence to a predicate device, rather than providing comprehensive study results against specific performance criteria. The provided text indicates that:

Technological characteristics: "All of the components of Ionolux are found in the legally marketed device GC Fuji II LC improved (K961584, GC America, Inc.)"
Safety and effectiveness: "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."

This essentially states that the device is considered safe and effective because its components are already used in a legally marketed predicate device, and therefore, extensive new testing (like a standalone performance study with detailed acceptance criteria) was deemed unnecessary for this 510(k) submission.

Therefore, I cannot provide the requested information from the given text. The document focuses on regulatory approval through substantial equivalence, not on a detailed performance study with explicit acceptance criteria.

Summary

{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:

1. Restorations class III and V, especially cervical fillings and root caries
1. Fillings on deciduous teeth
1. Small class I fillings
1. Temporary fillings
1. Core build-up
1. 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:

1. Restorations class III and V, especially cervical fillings and root caries -
1. Fillings on deciduous teeth
1. Small class I fillings
1. Temporary fillings
1. Core build-up
1. Lining

Prescription Use

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

Regulation Number and Section

§ 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.