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K Number
K981370
Device Name
MIRACLE MIX CAPSULE
Manufacturer
GC AMERICA, INC.
Date Cleared
1998-06-01

(47 days)

Product Code
EMA
Regulation Number
872.3275
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Indications for Use: Miracle Mix is a self cure silver alloy glass ionomer cement intended for use as a dental restorative available in premeasured single use capsules.

Device Description

Miracle Mix is a self cure silver alloy glass ionomer cement intended for use as a dental restorative available in premeasured single use capsules.

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental restorative device called "Miracle Mix Capsule Modification." It signifies that the device is substantially equivalent to a predicate device already on the market.

However, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The letter primarily focuses on:

  • Device Identification: Miracle Mix Capsule Modification
  • Regulatory Classification: Class II
  • Product Code: EMA
  • Date of Clearance: June 1, 1998
  • Indications for Use: "Miracle Mix is a self cure silver alloy glass ionomer cement intended for use as a dental restorative available in premeasured single use capsules."
  • General Controls: The device is subject to general controls provisions of the Act, including annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

Therefore, I cannot provide the requested table and information as the source document does not contain this type of data.

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.