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K Number
K033045
Device Name
DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST
Manufacturer
AMERICAN GREEN DENT. MFG, INC.
Date Cleared
2003-12-23

(85 days)

Product Code
EJH
Regulation Number
872.3710
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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.

Device Description

General:- Dental Alloys
Specific :- "DREAMBOND""DREAMCAST CHROME" "DREAMCAST V" "DREAM FLEXICAST" "DREAM LITHECAST"

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the Dream Bond, DreamCast V, DreamCast Chrome, Dream FlexiCast, and Dream LitheCast devices.

The document is a 510(k) premarket notification letter from the FDA to American Green Dental Manufacturing, Inc. It states that the referenced devices are substantially equivalent to legally marketed predicate devices. This means that the FDA has determined the new devices are as safe and effective as existing ones, but it does not detail specific acceptance criteria or performance studies of the devices themselves within this document.

The document focuses on:

  • FDA's determination of substantial equivalence (K033045).
  • Regulation numbers and product codes for the devices.
  • General controls and additional controls that may apply.
  • Contact information for various FDA offices.
  • Indications for Use for each device.
  • Classification as Prescription Use.

Therefore, I cannot provide the requested information based on the text provided.

§ 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.