(79 days)
SEcure Adhesive Dental Cement is a dual-cure, self-etching, adhesive dental cement system. It is intended for indirect cementation of porcelain, ceramic, resin, and metalbased inlays, onlays, crowns, bridges, veneers and posts.
SEcure is a dual-cure, self-etching, adhesive dental cement system consisting of a self-etching primer and a two-part dental cement. The self-etching primer is supplied in a single bottle, while the dental cement is supplied in a double-barrel auto-mix syringe. The cement system does not require acid etching of tooth surfaces, and can be cured with any available curing light.
I am sorry, but the provided text does not contain the information required to answer your request. The document is a 510(k) summary for a dental cement, focusing on its description, intended use, and substantial equivalence to predicate devices for regulatory approval. It does not include details about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement as typically found in a clinical study report or performance evaluation chapter.
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510(k) SUMMARY
| Submitter: | Parkell, Inc.300 Executive DriveEdgewood, NY 11717TEL: 631-249-1134FAX: 631-249-1242 | MAR 19 2008 |
|---|---|---|
| Contact: | Daniel R. Schechter, Esq.General CounselParkell300 Executive DriveEdgewood, NY 11717 | |
| Submission Date: | 28 December 2007 | |
| Trade Name: | SEcure | |
| Common Name: | Dental Cement | |
| Classification Name: | Dental Cement | |
| Equivalence: | TOTALBOND, MAXCEM, UNICEM | |
| Description/Intended Use: | SEcure is a dual-cure, self-etching, adhesive dentalcement system consisting of a self-etching primer and atwo-part dental cement. The self-etching primer issupplied in a single bottle, while the dental cement issupplied in a double-barrel auto-mix syringe. Thecement system does not require acid etching of toothsurfaces, and can be cured with any available curinglight. The intended use of SEcure is for indirect |
posts.
:
cementation of porcelain, ceramic, resin and metalbased inlays, onlays, crowns, bridges, veneers and
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 9 2008
Mr Daniel R. Schechter, Esq. Parkell, Incorporated 300 Executive Drive Edgewood, New York 11717
Re: K073698
Trade/Device Name: SEcure Adhesive Dental Cement Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: December 28, 2007 Received: December 31, 2007
Dear Mr. Schechter:
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 - Mr. Schechter
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 (OS) 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.
Susan Runner
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):
Ko73698
Device Name: SEcure Adhesive Dental Cement
Indications for Use:
SEcure Adhesive Dental Cement is a dual-cure, self-etching, adhesive dental cement system. It is intended for indirect cementation of porcelain, ceramic, resin, and metalbased inlays, onlays, crowns, bridges, veneers and posts.
Prescription Use X (21 CFR Part 801 Subpart D) AND/OR
Over-The-Counter Use (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 Gunner
Division Sign-Off) ivision of Anesthesiology, General Hospital ntection Control, Dental Devices
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10(k) Number. K73658
§ 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.