(39 days)
This device is a "yellow-gold" colored, soldering alloy for use in the construction and repair of crown and bridge dental prosthetic devices. According to 21 CFR Ch. 1 (4-1-89 Ed.) Part 872. the classification name for this device is Gold Based Alloy and Precious Metal Alloys for Clinical Use, a Class II device.
"yellow-gold" colored, soldering alloy
This is a 510(k) premarket notification letter from the FDA regarding a "Yellow-Gold" Colored, Soldering Alloy (Trade Name: Aalba Gold Solder) from Aalba Dent, Incorporated. This document is a clearance letter, not a study report, so it does not contain the specific information requested about acceptance criteria and device performance studies.
Therefore, I cannot provide the requested information:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- If a standalone performance study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
This document only states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, which allows it to proceed to the market. It references compliance with general controls provisions and Good Manufacturing Practice requirements, but does not detail specific performance studies conducted by the manufacturer for this clearance.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Vincent Benetti General Manager Aalba Dent, Incorporated · AUG 1 5 1997 400 Watt Drive Cordelia, California 94585
K972532 Re: "Yellow-Gold" Colored, Soldering Alloy Trade Name: Regulatory Class: II Product Code: EJT Dated: July 2, 1997 Received: July 7, 1997
Dear Mr. Benetti:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the marroo is substantially equivalent (for the indications for use stated in the enclosure) to 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 The general controls provisions of the Act 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 requlations 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 requirement, as set forth in the Quality System Requlation (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 requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Benetti
through 542 of the Act for devices under the Electronic chrough 312 or on introl 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 marrees 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) 594-4618. 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" (21 CFR 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/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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K972532 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Aalba Gold Solder Device Name :_________________________________________________________________________________________________________________________________________________________________
Indications For Use: - - - ---- -
This device is a "yellow-gold" colored, soldering alloy for use in the construction and repair of crown and bridge dental prosthetic devices. According to 21 CFR Ch. 1 (4-1-89 Ed.) Part 872. the classification name for this device is Gold Based Alloy and Precious Metal Alloys for Clinical Use, a Class II device.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED. )
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suen Runner
(Division Sion-Off Division of Dental. and General Hospita 5 1 O(k) Number
ન્ડ Prescription Use OR (Per 21 CFR 801.109)
Over-The Counter Use_NO
(Optional Format 1-2-96)
§ 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.