(65 days)
APOLLO 3 ALLOY is indicated as a dental alloy for fabricating inlays, crowns and small span bridges.
APOLLO 3 ALLOY is a yellow, high noble, gold-based dental alloy.
The provided document is a 510(k) summary for a dental alloy, APOLLO 3 ALLOY. It does not describe an AI/ML powered device, nor does it present any studies involving human readers, ground truth establishment, or performance metrics typically associated with AI/ML devices. Therefore, I cannot extract the requested information related to AI/ML device acceptance criteria and study details from this document.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Degulor M Alloy K951779) based on its material composition, historical use, and biocompatibility testing. It states that APOLLO 3 ALLOY was found to be non-cytotoxic and non-mutagenic, and that other components have been used in legally marketed devices.
If you have a document pertaining to an AI/ML powered device, please provide that for analysis.
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510(k) SUMMARY
DENTSPLY
NAME & ADDRESS:
ENTSPLY International
OCT = 1 2003
0 West College Avenue PA 17405-0877
P. J. Lehn Telefax (717) 849-4343
CONTACT: P. Jeffery Lehn
DATE PREPARED: July 25, 2003
TRADE OR PROPRIETARY NAME: APOLLO 3 ALLOY
CLASSIFICATION NAME: Gold-based alloy for clinical use (872.3060)
PREDICATE DEVICES: Degulor M Alloy K951779
DEVICE DESCRIPTION: APOLLO 3 ALLOY is a yellow, high noble, gold-based dental alloy.
INTENDED USE: APOLLO 3 ALLOY is indicated as a dental alloy for fabricating inlays, crowns and small span bridges.
TECHNOLOGICAL CHARACTERISTICS: All of the components found in APOLLO 3 ALLOY have been used in legally marketed devices.
APOLLO 3 ALLOY is very similar in formulation to legally marketed dental alloys. This alloy has been on the European market since 1978 with over 2 million units placed. APOLLO 3 ALLOY was tested for Cytotoxicity and AMES mutagenicity and found to be non-cytotoxic and non-mutagenic. Therefore, it was determined that no further biocompatibility testing was necessary
We believe that the prior use of the components of APOLLO 3 ALLOY in legally marketed devices, the performance data provided, the biocompatibility test results, and the historical use of the device in Europe support the safety and effectiveness of APOLLO 3 ALL.O Y for the indicated uses.
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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT = 1 2003
Mr. P Jeffery Lehn Director of Corporate Compliance and Regulatory Affairs Dentsply International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872
Re: K032320
Trade/Device Name: Apollo 3 Alloy Regulation Number: 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: July 25, 2003 Received: July 28, 2003
Dear Mr. Lehn:
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. Lehn
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. 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 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 vours,
Susan Runnen
Susan Runner, DDS, MA Interim 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 STATEMENT
(As Required by 21 CFR 807.87(e)
510(K) Number (if known):
Device Name:
APOLLO 3 ALLOY
Indications for Use:
Fabricating inlays, crowns and small span bridges.
Melloh la KPM
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K032320
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR
QED. 2.0.1.1.0.0
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
§ 872.3060 Noble metal alloy.
(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.