(61 days)
Jewel Cast Plus is a dental alloy that is designed for use as crowns, bridges and substrate for high expansion low fusing dental porcelains and indirect composites.
Jewel Cast Plus is a dental alloy that is designed for use as crowns, bridges and substrate for high expansion low fusing dental porcelains and indirect composites. Jewel Cast Plus is substantially equivalent to Pentron Laboratory Technologies, LLC., Jewel Cast III with the exception of an element. However, addition of an element does not affect safety and effectiveness because it dramatically improves the corrosion resistance of the alloy. Also, Molybdenum has been used successfully in dental alloys for over 30 years.
This document is a 510(k) summary for a dental alloy, Jewel Cast Plus. It states that the device is substantially equivalent to a predicate device, Jewel Cast III, with the exception of an added element (Molybdenum) to improve corrosion resistance. However, it does not contain the detailed study information or acceptance criteria you've requested.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, data provenance, ground truth establishment, or expert involvement in a study, as this information is not present in the provided text.
The text solely focuses on the substantial equivalence determination for a dental alloy based on its composition and an assertion regarding its improved corrosion resistance, rather than detailing a performance study with specific acceptance criteria.
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510(K) SUMMARY 21.0
DEC 1 8 2002
KO2 352
Jewel Cast Plus is a dental alloy that is designed for use as crowns, bridges and substrate for high expansion low fusing dental porcelains and indirect composites. Jewel Cast Plus is substantially equivalent to Pentron Laboratory Technologies, LLC., Jewel Cast III with the exception of an element. However, addition of an element does not affect safety and effectiveness because it dramatically improves the corrosion resistance of the alloy. Also, Molybdenum has been used successfully in dental alloys for over 30 years.
Pentron Laboratory Technologies, LLC. 510K Submission - Jewel Cast Plus
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boylevard Rockville MD 20850
Mr. Greg Jimmie Management Representative Pentron Laboratory Technologies, LLC 53 North Plains Industrial Road Wallingford, Connecticut 06492-0724
Re: K023502
Trade/Device Name: Jewel Cast Plus Regulation Number: 21 CFR 872.3710 Regulation Name: Base Metal Alloy Regulatory Class: II Product Code: EJH Dated: October 16, 2002 Received: October 18, 2002
Dear Mr. Jimmie:
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 vour 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. Greg Jimmie
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 cevice 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). 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 vours.
Patricia Cunliffe
Timothy A. Ulatowski 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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5.0 INDICATION FOR USE STATEMENT
510(k) NUMBER (IF KNOWN):
DEVICE NAME: Jewel Cast Plus
INDICATION FOR USE:
Jewel Cast Plus is a dental alloy that is designed for use as crowns, bridges and substrate fo high expansion low fusing dental porcelains and indirect composites.
(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 (Optional Format 1-2-96) રું..........................................................................................................................................................................
. Rums
(Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental Devices
Pentron Laboratory Technologies, LLC. 510K Submission -- Jewel Cast Plus
< 6.2 3 -510(k) Number
§ 872.3710 Base metal alloy.
(a)
Identification. A base metal alloy is a device composed primarily of base metals, such as nickel, chromium, or cobalt, that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Base Metal Alloys.” 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. See § 872.1(e) for availability of guidance information.