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K Number
K991974
Device Name
FUTURA GLASS IONOMER SILVER REINFORCED
Manufacturer
AB ARDENT
Date Cleared
1999-09-17

(98 days)

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

FUTURA GLASS IONOMER SILVER REINFORCED RESTORATIVE is to be used as a base, lining and filling material for restoring function to teeth which have lost portions to caries:

  • Class I and II cavities in deciduous teeth.
  • Repair of amalgam restored teeth (fractured restoration or tooth).
  • Class I and II cavities in selected permanent teeth.
  • Lining under amalgam or posterior composite restorations.
  • Cavities where radiopacity is a prime requirement.
  • Core build up material under crowns.
  • On root surface for locating overdentures.
  • Long term temporary replacement of cusps
  • Repairs to crown margins.
Device Description

Not Found

AI/ML Overview

I'm sorry, but the provided text does not contain the information requested about acceptance criteria and a study proving a device meets those criteria. The document is an FDA 510(k) clearance letter for a dental restorative material (Futura Glass Ionomer Silver Reinforced Restorative), indicating that the device is substantially equivalent to a legally marketed predicate device.

The information you've requested typically involves performance data, study designs, sample sizes, and expert qualifications, which are not detailed in this regulatory clearance letter. This letter primarily confirms that the device can be legally marketed based on its equivalence to existing products, rather than providing a comprehensive report on its clinical performance and the studies used to establish specific performance criteria.

§ 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.