(79 days)
Use Plastalgin for all routine impressions (e.g., denture dentition construction, orthodontics, study models, or other such routine impressions).
Use Plastalgin Ortho when a faster setting time is needed (e.g., procedure with children, patients with nauseous reflex during impression procedures).
Not Found
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for two dental impression materials, Plastalgin and Plastalgin Ortho. This document does not contain any information about acceptance criteria, device performance results from a study, sample sizes, expert qualifications, adjudication methods, or MRMC studies.
The letter primarily:
- Confirms the device is substantially equivalent to a legally marketed predicate device.
- States the regulation number, name, and product code.
- Outlines general control provisions of the Act that the manufacturer must comply with.
- Provides contact information for further guidance.
- Includes an "Indications for Use" statement for the devices.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.
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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. Inside the circle is a stylized image of an eagle or other bird, with three lines representing the wings and head of the bird.
Public Health Service
NOV 2 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEPTODONT C/O Mr. Wayne H. Matelski, Esq. Counsel for Septodont Arent Fox Kintner Plotkin & Kahn, PLLC 1050 Connecticut Avenue, NW Washington, District of Columbia 20036-5339
Re: K032708
Trade/Device Name: Plastalgin and Plastalgin Ortho Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: November 13, 2003 Received: November 14, 2003
Dear Mr. Matelski:
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. Wayne H. Matelski, Esq.
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 (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.
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 (301) 594-4613. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Signature
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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Indications for Use
510(k) Number (if known): K032708
Device Name: Plastalgin and Plastalgin Ortho
Indications For Use:
Use Plastalgin for all routine impressions (e.g., denture dentition construction, orthodontics, study models, or other such routine impressions).
Use Plastalgin Ortho when a faster setting time is needed (e.g., procedure with children, patients with nauseous reflex during impression procedures).
Prescription Use _ ___________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suse Burns
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
KOBOZOR 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).