(225 days)
CERCOM II Cement is a self-adhesive cement recommended for the bonding of ceramic, metal and composite restorations.
CERCOM II Cement is a self-adhesive cement recommended for the bonding of ceramic, metal and composite restorations. CERCOM II has the same technological characteristics (intended use, application mechanism) as the predicate device CERCOM, except that CERCOM II is a dual-cure cement. CERCOM II can set on its own as well as set with visible light cure.
This looks like a regulatory approval document (510(k) Summary) for a dental cement, not a study describing the performance of a medical device against acceptance criteria. Therefore, the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in the provided text.
The document states that the CERCOM II Cement is "substantially equivalent in design, composition, performance, intended use and effectiveness to the predicate cement products cited." This means it was approved based on its similarity to previously cleared devices, rather than a new standalone clinical trial with specific performance metrics and acceptance criteria.
To answer your request, I would need a document specifically detailing a performance study for a device, including its acceptance criteria and the results of that study.
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K13 2393
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ali corporation
131100d Washington Studi 11.100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
1 70, 826, 910, 9 : "KI 12-11-14-11 13 வர் விச்சர்களையும் கா
510 (k) Summary
November 25, 2013
ADDRESS
DENALI CORPORATION 134 Old Washington Street Hanover, MA 02339-1629 OWNER/CONTACT PERSON Dr. Jan G. Stannard TEL: 781-826-9190 FAX: 781-826-4465 j.stannard@denalicorporation.com TRADE NAME CERCOM II COMMON NAME Resin Cement CLASSIFICATION NAME DENTAL CEMENT (21 CFR 872.3275, Product Code EMA) REGISTRATION 3006367836 PREDICATE DEVICES Cercom Cement/Denali Corporation - RelyX Cement/ESPE/3M Variolink Cement/Ivoclar - Calibra Cement/Dentsply - Nexus Cement/Kerr EQUIVALENCE The predicate products have been found substantially equivalent under the 510(k) premarket notification process as Class II Dental Devices under CFR EMA 872.3275, Dental Cement. DEVICE DESCRIPTION CERCOM II Cement is a self-adhesive cement recommended for the bonding of ceramic, metal and composite restorations. INTENDED USE CERCOM II Cement is a self-adhesive cement recommended for the bonding of ceramic, metal and composite restorations. CERCOM II has the same technological characteristics (intended TECHNOLOGICAL CHARACTERISTICS use, application mechanism) as the predicate device CERCOM, except that CERCOM II is a dual-cure cement. CERCOM II can set on its own as well as set with visible light cure. SUBSTANTIAL CERCOM II Cement is substantially equivalent in design. EQUIVALENCE composition, performance, intended use and effectiveness to the predicate cement products cited. This assessment is based upon a comparison of the physical characteristics, mechanisms of use description, intended use, composition, and mechanical properties of the cited predicate products. SUMMARY CONCLUSIONS CERCOM II Cement has been found to be substantially equivalent
in design, composition, performance, intended use and effectiveness to the predicate cement products cited.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 14, 2014
Denali Corporation Dr. Jan G. Stannard 134 Old Washington Street Hanover, MA 02339-1629
Re: K132393
Trade/Device Name: CERCOM II Cement Regulation Number: 21 CFR 872.3275 Regulation Name: Resin Cement Regulatory Class: II Product Code: EMA Dated: December 4, 2013 Received: December 6, 2013
Dear Dr. Stannard:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Erin I. Keith -S
Erin 1. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510 (k) Number 132393 (if known)
Device Name
CERCOM II Cement
Indications for Use:
CERCOM II Cement is a self-adhesive cement recommended for the bonding of ceramic, metal and composite restorations.
Please do not write below this line. Continue on another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mary S. Runner -S
Susan Runner DDS, MD 2014.03.13
09:33:50 -04'00'
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Prescription Use (Per 21 CFR 801.109) or
Over-The-Counter Use
§ 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.