(80 days)
SECURALLOY ™ is a dental amalgam for use in the obturation of the cavities of posterior teeth and building of false stumps.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a dental amalgam device called SECURALLOY™. This document primarily concerns the regulatory approval of the device based on its substantial equivalence to a legally marketed predicate device.
This document DOES NOT contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies.
Therefore, I cannot provide the requested information based solely on this document. The letter only confirms that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent for its stated Indications For Use. The details about the studies conducted to demonstrate this equivalence would typically be found in the original 510(k) submission, not in the clearance letter itself.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 9 1998
Specialites Septodont C/O Mr. Peter S. Reichertz Counsel for Specialites Septodont Arent Fox Kintner Plotkin & Kahn, PLLC 1050 Connecticut Avenue N.W. Washington, DC 20036-5339
Re : K982671 Trade Name: SECURALLOY™ Requlatory Class: II Product Code: EJJ July 30, 1998 Dated: Received: July 31, 1998
Dear Mr. Reichertz:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Reichertz
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
thy A. Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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Enclosure
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510(k) Nunber (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
SECURALLOY ™ is a dental amalgam for use in the obturation of the cavities of posterior teeth and building of false stumps.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEROBOD)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runoer
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 198217 510(k) Number
Prescription Usc X (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
02/13 '96 11:07
§ 872.3070 Dental amalgam, mercury, and amalgam alloy.
(a)
Identification. Dental amalgam is a device that consists of a combination of elemental mercury, supplied as a liquid in bulk, sachet, or predosed capsule form, and amalgam alloy composed primarily of silver, tin, and copper, supplied as a powder in bulk, tablet, or predosed capsule form, for the direct filling of carious lesions or structural defects in teeth. This device also includes the individual component devices, mercury and amalgam alloy, when intended to be combined with each other to form dental amalgam.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy.”See § 872.1(e) for the availability of this guidance document.