(48 days)
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No
The summary describes a dental casting alloy and does not mention any software, algorithms, or AI/ML related terms.
No
The device is a dental casting alloy used to manufacture restorations like crowns and bridges; it is a material for a medical device rather than a therapeutic device that delivers therapy or treatment itself.
No
The provided text describes CONCORD 82 as a dental casting alloy used for restorations like crowns and bridgework. Its intended use is for manufacturing these dental prosthetics, not for diagnosing any medical condition.
No
The device is a dental casting alloy, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a dental casting alloy used for creating dental restorations (crowns, bridges). This is a material used in the body or for creating devices that go in the body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. The provided description does not involve any such testing.
The device is a dental material, not a diagnostic test.
N/A
Intended Use / Indications for Use
CONCORD 82 (PM-41) is a yellow colored gold/platinum dental casting alloy for restorations subject to high stress and that require porcelain enamels be fused to some of the surfaces. It may also be used as a Type IV (Extra Hard) crown and bridge alloy. It is intended for use in the manufacture of single units, % crowns, and short-span and long-span bridgework.
Product codes
EJT
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 6 2001
Mr. John C. Constantine Secretary/Treasurer Gateway Alloys, Incorporated 1702 Scherer Parkway 63303 Saint Charles, Missouri
K011628 Re : Concord 82 Trade/Device Name: 872.3060 Regulation Number: Regulatory Class: II Product Code: EJT Dated: May 29, 2001 Received: May 29, 2001
Dear Mr. Constantine:
We have reviewed your Section 510(k) notification of intent to we have reviewed your beceion beve and we have determined the market the device referenced above and word indications for device is substancially equivaled by marketed predicate use stated in the encrobare, es accessed prior to May 28, 1976, devices marketed in theerbead on Device Amendments, or to
the enactment date of the Medical Device arradongs with the the enactment date of che nassified in accordance with the devices that have been recraobiler, and Cosmetic Act (Act).
provisions of the Federal Food, Drug, and Cosmete the general provisions of the reacrain toom device, subject to the general controls provisions of the Act. The general controls controls provisions of the requirements for annual provisions of the Act incrace esquestmanufacturing practice, registration, freeing - or a stainst misbranding and adulteration.
If your device is classified (see above) into either class II II your device Is crabbless III (Premarket Approval), it may (Special Controls) of Stippil controls. Existing major be subject to such addreibler can be found in the Code of regulations arrecting your ac vita es 800 to 895. A rederal kegulations, frees to, ination assumes compliance with Substantly equivalence aring Practice requirements, as set the Current Good hands and the System Regulation (QS) for Medical Lorth In the Quarrey Bysoom (21 CFR Part 820) and that, Devices. Ocherar QS inspections, the Food and Drug Chrough Deriodic QB Inbpeoseity such assumptions. Failure to Administration (121) regulation may result in regulatory comply with the orn regaration forther announcements
1
Page 2 - Mr. Constantine
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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4622. 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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral 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/dsma/dsmamain.html".
Sincerely yours,
K.J. Wilkinson
Timothy 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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62
(510 (k) Number: _____________________________________________________________________________________________________________________________________________________________
Device Name: _CONCORD 82
Indications for Use: CONCORD 82 (PM-41) is a yellow colored gold/platinum dental casting alloy for restorations subject to high stress and that require porcelain enamels be fused to some of the surfaces. It may also be used as a Type IV (Extra Hard) crown and bridge alloy. It is intended for use in the manufacture of single units, % crowns, and short-span and long-span bridgework.
(Please do not write below this line)
| Prescription Use
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| (Pex 21 CFR 801.109 |
Over-the-Counter-Use
Suan Kinney
OR
Division Sign-Off) rann of Dental, Infection Control, si General riesp
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