(85 days)
HIGH SILVER CONVENTIONAL is to be used as a filling material for restoring function to teeth which have lost portions to caries:
Direct, fixed restorations, placed by the dentist after removal of carious tissue.
Single surface cavities such as Class I
Two surface cavities such as MO, DO, FO, LO
Three surface cavities such as MOD, FOD.
Pinned onlays and half crowns.
Core build-ups for cast half and full crowns.
For use only by dental professional such as DDS or DMD. Not for use by general public or OTC.
HIGH SILVER CONVENTIONAL
I am sorry, but the provided text does not contain the acceptance criteria or a study that proves the device meets specific acceptance criteria in the format you requested. The document is a 510(k) premarket notification letter from the FDA to AB Ardent regarding their "High Silver Conventional" amalgam alloy.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements. It also includes an "Indications for Use" section for the device. However, it does not detail specific performance metrics, acceptance criteria, or a study methodology that would allow me to populate the table and answer the study-related questions.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 0 7 2002
AB Ardent C/O Mr. Clyde E. Ingersoll Ardent Product Development Tonawanda, New York 14150-5260
Re: K020452
Trade/Device Name: High Silver Conventional Regulation Number: 872.3050 Regulation Name: Amalgam Alloy Regulatory Class: II Product Code: EJJ Dated: January 21, 2002 Received: February 11, 2002
Dear Mr. Ingersoll:
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.
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.
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Page 2 - Mr. Ingersoll
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timber 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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ARDENT
K *0 20452
HIGH SILVER CONVENTIONAL 510 (k)
ATTACHMENT #4
6
INDICATIONS FOR USE
510(k) Number: number not yet assigned
Device Name: HIGH SILVER CONVENTIONAL
HIGH SILVER CONVENTIONAL is to be used as a filling material for restoring function to teeth which have lost portions to caries:
Direct, fixed restorations, placed by the dentist after removal of carious tissue.
Single surface cavities such as Class I
Two surface cavities such as MO, DO, FO, LO
Three surface cavities such as MOD, FOD.
Pinned onlays and half crowns.
Core build-ups for cast half and full crowns.
For use only by dental professional such as DDS or DMD. Not for use by general public or OTC.
Labels will bear this caution.
Sumit Kumar
(Division Sign-Off) Division of Dental, Infection Control, Envision of Deman Misolion of Sevices
and General Hospital Devicess
51Olk) Number 510(k) Number _
§ 872.3070 Dental amalgam, mercury, and amalgam alloy.
(a)
Identification. Dental amalgam is a device that consists of a combination of elemental mercury, supplied as a liquid in bulk, sachet, or predosed capsule form, and amalgam alloy composed primarily of silver, tin, and copper, supplied as a powder in bulk, tablet, or predosed capsule form, for the direct filling of carious lesions or structural defects in teeth. This device also includes the individual component devices, mercury and amalgam alloy, when intended to be combined with each other to form dental amalgam.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy.”See § 872.1(e) for the availability of this guidance document.