(90 days)
For cementing dental posts inside prepared postholes, prior to rebuilding the missing coronal tooth structure.
Not Found
This document is a 510(k) clearance letter from the FDA for a dental cement product called "Sci-Pharm Post Secure." It indicates that the device has been found substantially equivalent to a legally marketed predicate device.
Crucially, this document is a regulatory approval letter and does not contain any information about acceptance criteria, study data, or performance metrics for the device. It's a notification of clearance, not a summary of a clinical or performance study.
Therefore, I cannot provide the requested information based on the provided text. The document states that the FDA "reviewed your Section 510(k) premarket notification of intent to market the device" and "determined the device is substantially equivalent." This determination is based on the information provided by the manufacturer in their 510(k) submission, which would include performance data, but that data itself is not present in this letter.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an image of an eagle. The eagle is depicted with its wings spread, symbolizing protection and service. The overall design is simple and professional, reflecting the department's role in public health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 3 2002
Ms. Jan A. Orlowski President Scientific Pharmaceuticals, Incorporated 3221 Producer Way Pomona, California 91768
Re: K013555
Trade/Device Name: Sci-Pharm Post Secure Regulation Number: 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: October 23, 2001 Received: October 25, 2001
Dear Ms. Orlowski:
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.
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.
{1}------------------------------------------------
Page 2 - Ms. Orlowski
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
A. Ulatowski Timothy Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the logo for SCI-PHARM. To the left of the text is a graphic of two Erlenmeyer flasks. To the right of the text is a mortar and pestle with the registered trademark symbol.
POST SECURE Indications for Use
For cementing dental posts inside prepared postholes, prior to rebuilding the missing coronal tooth structure.
Dr. Van A. Orlowski President
-
- 2001
Date
Susan Russo
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _
§ 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.