(98 days)
A dual-cure, tooth shade, resin composite for the restoration of Class I, II, III, IV and V cavities in permanent and deciduous teeth.
A radiopaque, dual-cure, two-paste, resin composite restorative for use in all class cavities as the final restration. May also be used as a core material. It is supplied in 25ml, auto-mixing cartridges and employs components commonly used in predicate devices.
This is a 510(k) premarket notification for a medical device. The provided text is heavily focused on the administrative aspects of the submission and the FDA's response, rather than a detailed technical study section. Therefore, the requested information about acceptance criteria, device performance, and study details is not present in the provided document.
The document discusses:
- Submission details (submitter, contact, date, trade name, common name, classification, equivalence, description/intended use).
- FDA's letter of substantial equivalence.
- Indications for Use.
There is no section detailing a study that proves the device meets acceptance criteria. The document explicitly states: "Although biocompatibility testing was deemed to be non-essential, lab results are included as part of this submission. These indicate the material is biocompatible and non-mutagenic." This suggests that extensive performance studies (especially clinical ones) were not central to this particular 510(k) submission, likely due to the nature of the device and its substantial equivalence to predicate devices.
Therefore, I cannot provide the requested table or answer the specific questions about sample size, expert ground truth, adjudication, MRMC studies, standalone performance, types of ground truth, or training set details.
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K0262518
510(k) SUMMARY
| Submitter: | Parkell, Inc.155 Schmitt Blvd.Box 376Farmingdale, NY 11735TEL: 631-249-1134FAX: 631-249-1242 | DEC - 4 2006 |
|---|---|---|
| Contact: | Nelson J. Gendusa, DDSDirector of ResearchParkell155 Schmitt Blvd.Box 376Farmingdale, NY 11735 | |
| Submission Date: | 8 August 2006 | |
| Trade Name: | Currently Not Available | |
| Common Name: | Resin Composite Restorative | |
| Classification Name: | Tooth Shade Resin Material | |
| Equivalence: | ABSOLUTE DENTIN, MARATHON DUAL-CURECOMPOSITE, PERMAFLO DC and MULTICURECOMPOSITE CEMENT | |
| Description/Intended Use: | A radiopaque, dual-cure, two-paste, resin compositerestorative for use in all class cavities as the finalrestration. May also be used as a core material. It issupplied in 25ml, auto-mixing cartridges and employscomponents commonly used in predicate devices.Although biocompatibility testing was deemed to be non-essential, lab results are included as part of thissubmission. These indicate the material is biocompatibleand non-mutagenic. |
. . . .
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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right. The eagle is depicted in a simple, line-art style.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Nelson J. Gendusa Director of Research Parkell, Incorporated 300 Executive Drive Edgewood, New York 11717
DEC = 4 2006
Re: K062518
Trade/Device Name: Celerity Regulation Number: 872,3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: November 22, 2006 Received: November 29, 2006
Dear Dr. Gendusa:
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.
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Page 2 - Dr. Gendusa
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 vour 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 Lin, Ph.D.
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
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Indications for Use
510(k) Number (if known): Unknown
Device Name: SRM-DC-05-10-06 Indications for Use:
A dual-cure, tooth shade, resin composite for the restoration of Class I, II, III, IV and V cavities in permanent and deciduous teeth.
Prescription Use X
AND/OR
Over-The-Counter Use
(21 CFR Part 801 Subpart D)
(21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runne
ංග Sign-Off) ion of Anesthesiology, General Hospital, on Control, Dental Devices
Number. K062578
Page 1 of 1
§ 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.