(49 days)
BEAUTIFIL II is a visible light curing dental filling composite resin having radiopacity, which is used for various restorations. It is suitable for filling and repairing for anterior and posterior, such as class I through V restorations, wedge shaped defects and root caries. It can be also applied to core build-up and repair of fractured laminate veneer, porcelain, composite resin and C&B materials.
BEAUTIFIL II is a visible light curing dental filling composite resin having radiopacity.
The provided document is a 510(k) clearance letter from the FDA for a dental filling composite resin named "Beautifil II" (K071742). It indicates that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain the specific information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement.
The letter focuses on regulatory approval based on demonstrating substantial equivalence, not on providing detailed performance data from a specific study against pre-defined acceptance criteria. The indications for use are mentioned, but no performance metrics are listed.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: Not present.
- Sample sizes used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
- Adjudication method for the test set: Not present.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not present.
- If a standalone study was done: Not explicitly detailed with performance metrics. The letter implies comparison to a predicate, not standalone performance against acceptance criteria.
- The type of ground truth used: Not present.
- The sample size for the training set: Not present.
- How the ground truth for the training set was established: Not present.
The document's purpose is to grant marketing clearance, not to publish detailed study results. Such study details would typically be found in the 510(k) submission itself, which is not publicly available in this format, or in associated clinical publications.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's emblem, which is a stylized depiction of an eagle or bird-like figure with three overlapping lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 5 2007
Mr. David Morais Operations Manager and Official Correspondent Shofu Dental Corporation 1225 Stone Drive San Marcos, California 92078-4059
Re: K071742
Trade/Device Name: Beautifil II Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: June 21, 2007 Received: June 27, 2007
Dear Mr. Morais:
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 Federal Register.
{1}------------------------------------------------
Page 2 - Mr. Morais
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" (21CFR Part 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu, Li-Pi, D.D.S.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known): K071742
Device Name: Beautifil II
Indications For Use:
BEAUTIFIL II is a visible light curing dental filling composite resin having radiopacity, which is used for various restorations. It is suitable for filling and repairing for anterior and posterior, such as class I through V restorations, wedge shaped defects and root caries. It can be also applied to core build-up and repair of fractured laminate veneer, porcelain, composite resin and C&B materials.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
X
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Penner
ാട്ടിon Sign-Off) Civision of Anesthesiology, General Hospital Shofu Dental Corporation Onora Dental Ochton Corporation Instition Control, Dental Devices
Number: 16071246
§ 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.