(90 days)
Algetral and Cavex Chromatic are dental impression materials based on alginate. They are used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. They are general purpose impression materials for making study models, first impressions for the construction of individual trays, situation models, orthodontic impressions etc.
Cavex Chromatic has the special characteristic of being a color-changing alginate: it becomes violet upon contact with water in the mixing bowl, changes to pink indicating the end of the mixing time and then finally changes to off-white indicating the end of the setting time in the mouth.
Algetral and Cavex Chromatic are dental impression materials based on alginate.
This is a letter about the substantial equivalence of a medical device (dental impression materials) to legally marketed predicate devices. It does not contain information about acceptance criteria, device performance, or a study proving device performance as it is a 510(k) clearance letter, not a detailed study report. Therefore, I cannot extract the requested information from the provided text.
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Public Health Service
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 17 1998
Mr. Bernard van Duijn Manager Technical Services Cavex Holland BV Harmenjansweg 19-21 P.O. Box 852 2003 RW Haarlem (Holland)
Re : K981970 Trade Name: CA 37 Superior Pink, CA 37 Fast Set, Cavex Rainbow, Cavex Impressional Normal Setting, Cavex Impressional Fast Setting, Algetral, Cavex Chromatic, Alginoplast Normal Setting, Alginoplast Fast Setting; and Xantalqin Select Regulatory Class: II Product Code: ELW Dated: May 14, 1998 Received: June 4, 1998
Dear Mr. Bernard van Duijn:
This letter corrects our substantially equivalent letter of September 2, 1998, regarding the product name.
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 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). 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General (QS) regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug
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Page 2 - Mr. Bernard van Duijn
Administration (FDA) may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obliqation 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.
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 regulation (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. Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address
"http://www.fda.qov/cdrh/dsmamain.html".
Sincerely yours,
Susan Kunner
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) NUMBER (IF KNOWN) :
DEVICE NAME: Algetral and Cavex Chromatic Alginate Impression Materials
INDICATIONS FOR USE:
Algetral and Cavex Chromatic are dental impression materials based on alginate. They are used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. They are general purpose impression materials for making study models, first impressions for the construction of individual trays, situation models, orthodontic impressions etc.
Cavex Chromatic has the special characteristic of being a color-changing alginate: it becomes violet upon contact with water in the mixing bowl, changes to pink indicating the end of the mixing time and then finally changes to off-white indicating the end of the setting time in the mouth.
(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)
Susan Runno
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 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).