(86 days)
Not Found
Not Found
No
The summary describes a dental alloy and does not mention any AI or ML components.
No
The device is described as a dental alloy for crowns and bridges, which is a material used for restoration, not a therapeutic device designed to treat or cure a disease or condition.
No.
The document describes a dental alloy for crowns and bridges, which is a restorative material used in treatment, not a device used to diagnose medical conditions.
No
The provided text describes a dental alloy, which is a physical material, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that SILCAST is a dental alloy designed for creating dental restorations like crowns and bridges. This is a material used in the mouth, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description identifies it as a base metal alloy for dental use.
- Lack of IVD Characteristics: The description 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 those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
Therefore, SILCAST is a dental material, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
SII CAST ( RD-0118 ) is a predominently base metal alloy under ADA and hard Crown and Bridge alloy. SILCAST with platinum-white color provides quality restorations and it polishes to a high lusture. This bace in and short span bridges.
Product codes
ETS
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
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized eagle symbol. The eagle is depicted with three lines forming its head and wings, creating a sense of movement and dynamism. The overall design is simple and professional, reflecting the department's role in public health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 1998
Mr. Tridib Dasgupta Director R & D and Q.C J.F. Jelenko & Company, Incorporated 99 Business Park Drive Armonk, New York 10504
K981247 Re : SILCAST (Code Name RD-0118) Trade Name: Regulatory Class: II Product Code: ETS Dated: April 2, 1998 Received: April 6, 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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A 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 general 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 R. Ulatowski
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
JELENKO DENTAL PRUD
JELENKO
J. F.
F. JELENKO & CO.
DENTAL HESS PARK DAIVE. ARMONK. NEW YOHK U.S.A. 10504 + (814) 273 - 860 1
Page / of /
510(k) Number (if known): K 981247
Device Name: SILCAST [Code Name: RD-0118]
Indications For Use:
SII CAST ( RD-0118 ) is a predominently base metal alloy under ADA and
er Type-March (2000) and arters for Dental alloy, It is designed for Type-III SII CAST ( RD-0118 ) is a predominently base included tor Treehard Crown and Bridge alloy.
hard Crown and Bridge alloy.
SILCAST with platinum-white color provides quality restorations and it SILCAST with platinum-white color provides quality itstore.com .
SILCAST with platinum-white color provides quality itsubres. polishes to a high lusture. This bace in and short span bridges.
Zridis Angri
6/25/98
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Beatrice Shuman
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
YES
OR
Over-The-Counter Use