(164 days)
Titanmagnetics are allowed to be used only in responsibility of a physician, dentist or maxillofacial surgeon for following indications: Gero-prosthetics Magnet attachment adaptable to different implants or root caps (post). Anchoring of hybrid and partial dentures in category nº III (toothless jaw) and category nº IIc (very few teeth left). The classification is according to the BDIZ-Expert Commitee 1997. For lower jaw (mandible) treatments belonging to category nº III; at least 2 to 4 implants shall be inserted, in the upper jaw (maxilla) at least 3 or 4 implants.
Not Found
I am sorry, but the provided text from the FDA 510(k) clearance letter for the STECO-TITANMAGNETICS device does not contain the specific information required to describe the acceptance criteria and the study that proves the device meets those criteria in the format you requested.
The document is a clearance letter, which means the FDA has determined the device is substantially equivalent to a predicate device already on the market. It does not typically detail the specific performance studies, acceptance criteria, sample sizes, or ground truth methods that would have been conducted by the manufacturer to support their 510(k) submission.
These details would be found in the actual 510(k) summary or the full 510(k) submission itself, which is a much more extensive document than this clearance letter.
Therefore, I cannot populate the table or answer the specific questions based on the information provided.
{0}------------------------------------------------
Image /page/0/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 1999 SEP
Steco-System-Technik GmbH & CoKG C/O Dr. rer. nat. Jorn Probst ZMK-Clinic, Department of Experimental Dentistry Pleicherwall 2 97070 Wurzburg, Bavaria GERMANY
Re : K990979 Steco-Titanmagnetics Trade Name: Regulatory Class: I Product Code: EGG Dated: August 13, 1999 Received: August 20, 1999
Dear Dr. Probst:
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 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations 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 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
{1}------------------------------------------------
Page 2 - Dr. Probst
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. 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
{2}------------------------------------------------
K 990979 510 (k) Number:
Device Name:
STECO-TITANMAGNETICS
Indications For Use:
General:
Titanmagnetics are allowed to be used only in responsibility of a physician, dentist or maxillofacial surgeon for following indications:
Gero-prosthetics
Magnet attachment adaptable to different implants or root caps (post). Anchoring of hybrid and partial dentures in category nº III (toothless jaw) and category nº IIc (very few teeth left). The classification is according to the BDIZ-Expert Commitee 1997. For lower jaw (mandible) treatments belonging to category nº III; at least 2 to 4 implants shall be inserted, in the upper jaw (maxilla) at least 3 or 4 implants.
Susar Runa
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number
Ka10979
(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)
ﺃﺳﺮ
OR
Over-The-Counter Use
§ 872.3165 Precision attachment.
(a)
Identification. A precision attachment or preformed bar is a device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended for use in prosthetic dentistry in conjunction with removable partial dentures. Various forms of the device are intended to connect a lower partial denture with another lower partial denture, to connect an upper partial denture with another upper partial denture, to connect either an upper or lower partial denture to a tooth or a crown, or to connect a fixed bridge to a partial denture.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.