(129 days)
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Not Found
No
The 510(k) summary describes a dental alloy, which is a material, not a software or system that would typically incorporate AI/ML. The description focuses on the material properties and intended use as a dental restoration. There are no mentions of AI, ML, image processing, or data analysis.
No
The device is a dental alloy used for crowns and bridges, which are restorative applications, not therapeutic. It replaces missing tooth structure but does not treat a disease or condition.
No
The device, BW-1, is described as a high noble alloy for dental restorations (crowns and bridges), not for diagnosing medical conditions.
No
The device description clearly states it is a "high noble alloy" and a "dental alloy," indicating it 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/Indications for Use: The description clearly states that BW-1 is a dental alloy used for crowns and bridges. This is a material intended for use within the body (or in direct contact with the body) for restorative purposes.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. The intended use of BW-1 does not involve analyzing biological samples.
- Lack of IVD-related information: The description does not mention any of the typical elements associated with IVDs, such as:
- Analyzing biological samples
- Detecting biomarkers or analytes
- Providing diagnostic information
Therefore, BW-1 is a dental material, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
BW-1 ( Code Name : RD-0807 ) is a high noble alloy under Identalloy and ADA classification system for Dental alloy. It is designed for porcelain application and compatible with low fusing porcelains in the market. It can also be used as Type-III crown and bridge alloy. BW-1 is copper and palladium free, rich yellow color alloy and it provides quality restoration. It polishes to a high luster and is suitable for Single and 3 to 4 crowns.
Product codes
EJT
Device Description
BW-1 (Code Name: RD-0807) is a high noble alloy designed for porcelain application and compatible with low fusing porcelains. It can also be used as a Type-III crown and bridge alloy. It is copper and palladium free, has a rich yellow color, and polishes to a high luster.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 3 1998
Mr. Tridib Dasgupta Director R & D and Q.C J.F. Jelenko & Company, Incorporated 99 Business Park Drive Armonk, New York 10504
K981244 Re: BW-1 (Code Name RD-0807) Trade Name: Requlatory Class: II Product Code: EJT Dated: July 14, 1998 Received: July 16, 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 Regulations, 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 Druq 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 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) 594-4692. 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,
S. Butman Pr
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 | J. F. JELENKO & CO. |
|---|---|
| DENTAL HEALTH PRODUCTS | |
| 99 BUSINESS PARK DRIVE, ARMONK, NEW YORK U.S.A. 10504 • (914) 273-8600 | |
| FAX: (914) 273-9379 |
Page _ of _
| Labels | Values |
|---|---|
| 510(k) Number (if known): | K981244 |
| Device Name: | BW-1 (Code Name: RD-0807) |
Indications For Use:
BW-1 ( Code Name : RD-0807 ) is a high noble alloy under Identalloy and ADA classification system for Dental alloy. It is designed for porcelain application and compatible with low fusing porcelains in the market. It can also be used as Type-III crown and bridge alloy. BW-1 is copper and palladium free, rich yellow color alloy and it provides quality restoration. It polishes to a high luster and is suitable for Single and 3 to 4 crowns.
River Doggett
7/14/98
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suomluorre
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital De
510(k) Number.
Prescription Use
(Per 21 CFR 801.109)
YES
OR
Over-The-Counter Use NO