(41 days)
Cavex Orthotrace alginate impression material is a dental impression material based on alginate. It is about taking impressions of the oral cavity with the purpose of constituting a gypsum cast that is a copy of the situation in the mouth. Cavex Orthotrace has an extra fast setting, high elasticity, high tear resistance, can be poured twice with gypsum and is proven Orthotrace is particularly suited for orthodontics
Cavex Orthotrace Alginate impression material
I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for a dental impression material named "Cavex Orthotrace," dated June 21, 2005. It confirms the device's substantial equivalence to legally marketed predicate devices.
The letter details the regulatory classification, general controls provisions of the Act, and contact information for further inquiries. However, it does not include any technical specifications, performance data, clinical study results, or information about acceptance criteria or how they were met. It merely states that the device is substantially equivalent for the indications for use.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, or details about study characteristics like sample size, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is absent in the provided text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 1 2005
Mr. Richard Woortman Manager, Technical Services Cavex Holland BV Harmenjansweg 19-21 P.O. Box 852 2003 RW Haarlem THE NETHERLANDS
Re: K051207
Trade/Device Name: Cavex Orthotrace Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: May 02, 2005 Received: May 11, 2005
Dear Mr. Woortman:
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. Richard Woortman
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that 1727 s issualled of a subscription with other requirements of the Act or that FDA nas made a decemination allar your as your Federal agencies. You must comply with any Pederal Statutes and regulations administered of taxistration and listing (21 CFR Part 807); all the Act s requirements, merading, but virus ments as set forth in the quality labeling (21 CFR 1 art 801); good manazations of applicable, the electronic product radiation systems (QB) rogalisons 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) This letter will anow you to oegin maing of substantial equivalence of your device to a legally premarked notheation: "The PDF mining sification 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 If you desire specific acrite int 70% (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other Misoranianing of relerence to promobilities under the Act from the Division of Small general international on your consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Oction http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu S. Lin, PhD
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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510(k) NUMBER (IF KNOWN):
DEVICE NAME: Cavex Orthotrace Alginate impression material
INDICATIONS FOR USE:
Cavex Orthotrace alginate impression material is a dental impression material based Gavex Ofthotraos alginate inity impressions of the oral cavity with the purpose of on algmate. It is aboution that is a copy of the situation in the mouth. Cavex constitucing a gypoum oact that is atisf, high elasticity, high tear resistance, can be Orthotrace has an oxtra fact betting and in a attractive fuchsia-coloured powder pource twice with gypount and is proven Orthotrace is particularly suited for orthodontics
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED. )
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-96)
Koin Muluy for MSR
Division of Anesthesiology. Gene
510(k) Number:
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).