(85 days)
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Not Found
No
The device description and intended use clearly indicate that these are dental casting alloys, which are materials used in dental laboratories. There is no mention of software, algorithms, or any technology that would incorporate AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The devices listed are dental casting alloys used in laboratories for fabricating dental restorations and applications, not for direct therapeutic use on patients.
No
The provided text describes dental alloys used for fabricating dental restorations and applications. It does not mention any function related to diagnosing diseases or conditions. The intended use is for material fabrication, not diagnostic assessment.
No
The device description clearly states "Dental Alloys" and lists specific alloy names, indicating a physical material, not software.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use of these devices is for the fabrication and preparation of dental restorations and applications in dental laboratories. This involves creating physical dental prosthetics.
- IVD Definition: IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
These dental casting alloys are materials used to build dental devices, not to analyze biological samples.
N/A
Intended Use / Indications for Use
"DREAMBOND" (Ceramic dental casting Alloy) is used in dental laboratories, suitable for fabrication of metal-ceramic dental restorations.
"DREAMCAST CHROME" (Partial Denture Dental Casting Alloy) is for the use in dental laboratories, suitable for preparation of removable dental applications.
"DREAMCAST V" (Cramic dental casting Alloy) is used in dental laboratories, suitable for fabrication of metal-ceramic dental restorations.
"DREAM FLEXICAST"" (Partial Denture Cobalt Base Alloy") is for the use in dental laboratories. suitable for preparation of removable dental applications.
"DREAM LITHECAST" (Ceramic dental casting Alloy Nickel & Beryllium Free) is used in dental laboratories, suitable for fabrication of metal-ceramic dental restorations.
Product codes
EJH
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
dental laboratories
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): 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
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§ 872.3710 Base metal alloy.
(a)
Identification. A base metal alloy is a device composed primarily of base metals, such as nickel, chromium, or cobalt, that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Base Metal Alloys.” The device is 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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three wing-like lines extending from its body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 3 2003
Mr. Andrew Rowe QA Manager American Green Dental Manufacturing, Inc. 3432 East 14th Street Los Angeles, California 90023
Re: K033045
Trade/Device Names: Dream Bond, DreamCast V, DreamCast Chrome, Dream FlexiCast, and Dream LitheCast Regulation Number: 21 CFR 872.3710 Regulation Name: Base Metal Alloy Regulatory Class: II Product Code: EJH Dated: December 06, 2003 Received: December 15, 2003
Dear Mr. Rowe:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Andrew Rowe
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4613. 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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 vours.
Chiu S. Lin, PhD
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) # K033045
Device Name:- General:- Dental Alloys
"DREAMBOND""DREAMCAST CHROME" "DREAMCAST V" Device Name:- Specific :- "DREAM FLEXICAST" "DREAM LITHECAST"
"DREAMBOND" (Ceramic dental casting Alloy) is used in dental laboratories, suitable for fabrication of metal-ceramic dental restorations.
"DREAMCAST CHROME" (Partial Denture Dental Casting Alloy) is for the use in dental laboratories, suitable for preparation of removable dental applications.
"DREAMCAST V" (Cramic dental casting Alloy) is used in dental laboratories, suitable for fabrication of metal-ceramic dental restorations.
"DREAM FLEXICAST"" (Partial Denture Cobalt Base Alloy") is for the use in dental laboratories. suitable for preparation of removable dental applications.
"DREAM LITHECAST" (Ceramic dental casting Alloy Nickel & Beryllium Free) is used in dental laboratories, suitable for fabrication of metal-ceramic dental restorations.
Prescription Use 4 (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-ONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kei Muly for MCR
Infection Control, Der
510(k) Number: K033045