(139 days)
Paste catalyst is used with a condensation-type silicone base paste or putty as a dental impression material to reproduce a patient's teeth and gums, and to provide models for study and for production of restorative prosthetic devices. The paste catalyst causes the base material to set.
Not Found
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth. The document is a 510(k) clearance letter from the FDA for a dental device called "Activator Paste," indicating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters, but no performance study details are included.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 3 2000
Ms. Mildred M. Goldstein President Harry J. Bosworth Company 7227 North Hamilton Avenue Skokie, Illinois 60076-3999
Re : K994027 Activator Paste Trade Name: Requlatory Class: II ELW Product Code: March 24, 2000 Dated: Received: April 5, 2000
Dear Ms. Goldstein:
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 devices marketed in interstate able beated in one enouses, 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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. ਸੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your
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Page 2 -Ms. Goldstein
premarket notification submission does not affect any obligation 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 requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4690. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K94027
Page 1 of 1
510(K) Number: K994027
... ...
Device Name: Activator Paste
INDICATIONS FOR USE:
Paste catalyst is used with a condensation-type silicone base paste or putty as a dental impression material to reproduce a patient's teeth and gums, and to provide models for study and for production of restorative prosthetic devices. The paste catalyst causes the base material to set.
(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)
물유용무료보보수속속속속으로부부부부분석으로쓰이용해주세요하십니아바이크사이트♣바둑이해주예약예약===========================================================================================================================
OR Over-the-Counter Use (Optional Format 1/2/96)
CONFIDENTIAL
510(k) Number J
(Division Sign-Off)
Division of Dental, Infection Contra
and General Hospital Devices
§ 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).