(58 days)
Fusion Core is a high strength core material that offers the convenience of light curing with excellent depth of cure that allows either the layering or the core form approach to build-up. Fusion Core cuts just like dentin without clogging the cutting bur as many other BIS-GMA containing materials. Fusion Core contains no BIS-GMA and is based upon a hydrophilic resin/filler combination.
Fusion Core is a high strength core material that offers the convenience of fight curing with excellent depth of cure that allows either the layering or the core form approach to build-up. Fusion Core cuts just like dentin without clogging the cutting bur as many other BIS-GMA containing materials. Fusion Core contains no BIS-GMA and is based upon a hydrophilic resinffiller combination
The provided text is a 510(k) premarket notification for a dental material called "Fusion Core Material." It asserts substantial equivalence to predicate devices and describes the product's properties and intended use. However, it does not contain any information about acceptance criteria, device performance metrics, or any studies conducted to prove the device meets specific criteria.
Therefore, I cannot provide accurate information for the requested points. The document focuses on regulatory approval based on substantial equivalence, not on detailed performance studies or statistical evidence.
Specifically, the following information is not present in the provided text:
- A table of acceptance criteria and the reported device performance: No specific performance metrics or acceptance criteria are defined or reported.
- Sample sized used for the test set and the data provenance: No test sets or data provenance are mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
- Adjudication method: Not applicable as no test set evaluation is described.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned. The document relies on substantial equivalence to existing dental materials.
- Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable, as this is a dental material, not a software algorithm.
- The type of ground truth used: No ground truth for performance is mentioned.
- The sample size for the training set: No training sets are mentioned.
- How the ground truth for the training set was established: No training sets or ground truth establishment are mentioned.
The document states: "The Fusion Core Material is substantially equivalent in design, composition, performance, intended use and effectiveness to the predicate kit products listed above." This statement, along with the quote from the NH Technology Assessment conference ("General usage of these materials over about 30 years indicates a high benefit-to-risk ratio... There is no evidence of short-term or long-term risk... There is no suspicion of any problems after virtually billions of procedures in the United States."), serves as the basis for the FDA's substantial equivalence determination, rather than a detailed, de novo study with specific performance metrics and acceptance criteria for this particular device.
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Fusion Core Materials
SUMMARY OF SAFETY AND EFFECTIVENESS DATA
Dr. Jan G. Stannard 134 Old Washington Street Hanover, MA 02339-1629
Telephone 781-826-9190 Fax 781-826-9190 j_stannard@comcast.net
DEVICE
Trade Name: Fusion Core Material Classification Name: Cement, Dental FDA Product Code: 872.3275
PREDICATE DEVICES: Clearfil Photo Core, Kurarav SuperCure, Centrix
Rebilda LC #. Voco EnCore, Centrix
MAY 1 0 2007
DESCRIPTION AND INTENDED USE:
Fusion Core is a high strength core material that offers the convenience of fight curing with excellent depth of cure that allows either the layering or the core form approach to build-up. Fusion Core cuts just like dentin without clogging the cutting bur as many other BIS-GMA containing materials. Fusion Core contains no BIS-GMA and is based upon a hydrophilic resinffiller combination
COMPARISON WITH PREDICATE PRODUCTS:
Fusion Core Material is substantially equivalent in design, composition and intended use to the products listed above.
SAFETY AND EFFECTIVENESS:
The Fusion Core Material is substantially equivalent in design, composition, performance, intended use and effectiveness to the predicate kit products listed above.
The predicate products have been found substantially equivalent under the 510(k) premarket notification process as Class II Dental Devices under CFR EBC 872.3765.
According to the NH Technology Assessment conference on Effects and Side-Effects of Dental Restorative Materials: "General usage of these materials over about 30 years indicates a high benetif-to-risk ratio ... both composites and glass ionomers are relatively trouble-free. There is no evidence of short-term or long-term risk...There is no suspicion of any problems after virtually billions of procedures in the United States.
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Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services (HHS). The seal features the HHS logo, which is a stylized caduceus with three snakes intertwined around a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Jan G. Stannard President Denali Corporation 134 Old Washington Street Hanover, Massachusetts 02339-1629
MAY 1 0 2007
Re: K070702
Trade/Device Name: Fusion Core Material Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: April 23, 2007 Received: April 25, 2007
Dear Dr. Stannard:
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 (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) 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 such 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 Eederal Register.
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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); 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.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 yours,
Susan Gunner
& 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
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Image /page/3/Picture/0 description: The image shows the logo for Denali Corporation. The logo consists of a stylized mountain peak with three curved lines above it, followed by the words "denali corporation" in a bold, sans-serif font. The mountain peak is black and white, while the text is black.
Fusion Core Material
INDICATIONS FOR USE STATEMENT
1-070702 510 (k) Number (if known)
Device Name
Fusion Core Material
Indications for Use:
Fusion Core is a high strength core material that offers the convenience of light curing with excellent depth of cure that allows either the layering or the core form approach to build-up. Fusion Core cuts just like dentin without clogging the cutting bur as many other BIS-GMA containing materials. Fusion Core contains no BIS-GMA and is based upon a hydrophilic resin/filler combination.
Please do not write below this line. Continue on another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Russo
a J. Andementology Coneral Hospical, on Control, Demail Devices
Number KG 7022
Prescription Use
(Per 21 CFR 801.109) √
or
Over-The-Counter Use
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.