(86 days)
Heat curing polymer for dental prosthesis used for the repair and extending of dentures, relining for completing metal dentures and for use in orthodontia.
Not Found
I am unable to provide a description of the acceptance criteria and study as the provided document is a 510(k) clearance letter for a dental device (Dentorium Convertible Acrylic) and does not contain information about acceptance criteria or supporting studies. It primarily states that the FDA has found the device to be substantially equivalent to a legally marketed predicate device.
The document discusses the regulatory classification, general controls, and compliance requirements for the device. It also includes an "Indications for Use" section (Page 2), which outlines what the device is intended for and its contraindications.
Therefore, I cannot extract the requested information from the provided text.
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Image /page/0/Picture/1 description: The image is a black and white circular seal. The seal contains the logo for the U.S. Department of Health and Human Services. The logo is a stylized image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the edge of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 5 2001
Dentorium Export, Limited C/O Mr. Richard C. Lanzillotto Aqent Nats Corporation 30 Northport Road 11789-1734 Sound Beach, New York
K011820 Re : Dentorium Convertible Acrylic Trade/Device Name: Regulation Number: 872.3760 Regulatory Class: II Product Code: EBI Dated: May 1, 2001 Received: June 11, 2001
Dear Mr. Lanzillotto:
We have reviewed your Section 510(k) notification of intent to we have reviewed your beosed above and we have determined the market the device really equivalent (for the indications for device is Bubbeanerally one) to legally marketed predicate use stated in the chierstate commerce prior to May 28, 1976, devices marketed in I the Medical Device Amendments, or to che enactment acco oen reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). provisions of the roasian the device, subject to the general controls provisions of the Act. The general controls controls provisions of include requirements for annual provision, or the ing 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 be subject to back addroid device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with bubbeancially oga Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Forch In Cho galation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug enrough porion (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory
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Page 2 - Mr. Lanzillotto
In addition, FDA may publish further announcements action. action. In addition, For may pages al Register. Please note: concerning your device in arranket notification submission does Unis response to your premaint have under sections 531 not arrect any obligation for devices under the Electronic Chrough 342 or the not is not is on other Federal laws or regulations.
This letter will allow you to begin marketing your device as fills recei will arrow formarket notification. The FDA described in your 510 m, promilence of your device to a legally marketed predicate device results in a classification for your marketed predicate device ruse sub device to proceed to the market.
If you desire specific advice for your device on our labeling II you debire operies and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on Compriance at (502) advertising of your device, please contact che promotion and adversions (301) 594-4639. Also, please note "Misbranding by reference to the regulation entitled, premarket notification" (21CFR 807.97). Other general premation on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, obtained from the Divisumer 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,
Timothy A. Ulatwoski 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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INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Indications for Use:
Dentorium Convertible Acrylic
R 611820
Heat curing polymer for dental prosthesis used for the repair and extending of dentures, relining for completing metal dentures and for use in orthodontia.
Contraindications:
May cause skin irritation. Avoid inhalation or ingestion.
(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
Lildata
(Division Sign-Off) Division of Dental, Infection Control and General Hospital Devices 15 : O(k) Number _
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.