(129 days)
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.
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.
I apologize, but the provided text is a 510(k) clearance letter from the FDA for a dental alloy device (BW-1). This document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
The letter acknowledges that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its FDA clearance. However, it does not provide details on:
- Acceptance criteria table or reported device performance.
- Sample sizes for test sets or data provenance.
- Number or qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study.
- Standalone (algorithm only) performance.
- Type of ground truth used.
- Sample size or ground truth establishment for training sets.
The document is purely an administrative clearance letter and lacks the technical study details you are requesting.
{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
§ 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.