(83 days)
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No
The document describes a dental alloy and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is a dental alloy used for crowns and bridges, not for treating a disease or condition.
No
The device is a dental alloy used for crowns and bridges, not for diagnosing medical conditions.
No
The device description clearly states it is a dental alloy, which is a physical material, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is a dental alloy used for making crowns and bridges. This is a structural component for dental restoration, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description reinforces its use as a dental alloy for creating dental prosthetics.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
Therefore, based on the provided information, Allround E (Code name: RD1710) is a dental material, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Allround E ( Code name: RD1710 ) is a platinum gray color, Copper free, palladium-silver, porcelain-to-metal alloy designed for low fusing porcelain in the market. It is a Noble alloy under Identalloy and ADA classification system for Dental alloy. It can also be used as Type-III crown and bridge alloy. It is suitable for single units, short--span bridge work and long span bridge work. Ideal for combination cases of PTM / PFM and Crowns.
Product codes
EJS
Device Description
Allround E (Code name: RD1710) is a platinum gray color, Copper free, palladium-silver, porcelain-to-metal alloy.
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
Dental
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 7 1999
Mr. Tridib Dasgupta Director R&D and Q.C J.F. Jelenko & Company, Incorporated 99 Business Park Drive Armonk, New York 10504
K984587 Re : Allround-E (Code Name RD 1710) Trade Name: Requlatory Class: II Product Code: EJS Dated: December 22, 1998 Received: December 24, 1998
Dear Mr. Dasgupta:
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 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). 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 reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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
1
Page 2 - Mr. Dasgupta
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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" (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,
Timothy A. Ulatowski
Direc cor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page
510(k) NUMBER (IF KNOWN): K984587
DEVICE NAME: Allround E (Code Name: RD1710)
INDICATIONS FOR USE:
Allround E ( Code name: RD1710 ) is a platinum gray color, Copper free, palladium-silver, porcelain-to-metal alloy designed for low fusing porcelain in the market. It is a Noble alloy under Identalloy and ADA classification system for Dental alloy. It can also be used as Type-III crown and bridge alloy. It is suitable for single units, short--span bridge work and long span bridge work. Ideal for combination cases of PTM / PFM and Crowns.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use No OR Over-The-Counter-Use (Per 21 CFR 801.109) (Optional Format 1-2-96) (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number.