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K Number
K102836
Device Name
BONASIL A+ IMPRESSION MATERIALS
Manufacturer
DMP LTD
Date Cleared
2011-01-13

(106 days)

Product Code
ELW
Regulation Number
872.3660
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
K143382,K152180
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Bonasil A* Impression Materials are intended to:

  • be placed on an impression tray (or injected directly into the mouth, depending on the technique and device) and used to reproduce the structure of a patient's teeth and gums;
  • provide models for study and for production of restorative prosthetics devices;

Indications for use:

  • BONASIL A* Putty (putty normal set, putty fast set, putty extra hard, lab putty) is to be used as a preliminary material for:
  • Two step putty/wash technique
  • Single step putty/wash technique
  • Functional peripheries
  • Crown/bridge work
  • Inlays, onlays
  • BONASIL A* Heavy (heavy normal set, heavy fast set) is to be used as a heavy body material for:
  • Two step putty/wash technique
  • Single step putty/wash technique
  • Functional peripheries
  • Crown/bridge work
  • Inlays, onlays
  • BONASIL A* Monophase (monophase normal set, monophase fast set) is to be used as a semi-heavy body material for:
  • Single step putty/wash technique
  • Functional peripheries
  • Crown/bridge work
  • Inlays, onlays
  • BONASIL A* Regular (regular normal set, regular fast set) is to be used as a medium body material for:
  • Two step putty/wash technique
  • Single step putty/wash technique
  • Functional peripheries
  • Reline impressions
  • Crown/bridge work
  • Inlays, onlays
  • BONASIL A* Light (light normal set, light fast set) is to be used as a light body material for:
  • Two step putty/wash technique
  • Single step putty/wash technique
  • Functional peripheries
  • Reline impressions
  • Crown/bridge work
  • Inlays, onlays
  • BONASIL A* Bonabite (bonabite fast set) is to be used as a light body material for:
  • Making accurate occlusal registrations
  • Standards bite registrations in the end bite position
  • Key material for needle point registration
  • Production of small model segments
  • An optical registration of occlusal data for CAD/CAM/CIM systems
  • BONASIL A* Alginate free (normal set, fast set) is an alternative to traditional alginate materials and is suitable for:
  • Preliminary impressions
  • Anatomic models
  • Fabricating temporary crowns and bridges
  • Opposing dentition
  • Fabricating simple removable prosthetic restorations
  • Orthodontic work
  • Case study models
Device Description

The Bonasil A* Impression Materials are intended to:

  • be placed on an impression tray (or injected directly into the mouth, depending on the technique and device) and used to reproduce the structure of a patient's teeth and gums;
  • provide models for study and for production of restorative prosthetics devices;

Indications for use:

  • BONASIL A* Putty (putty normal set, putty fast set, putty extra hard, lab putty) is to be used as a preliminary material for:
  • Two step putty/wash technique
  • Single step putty/wash technique
  • Functional peripheries
  • Crown/bridge work
  • Inlays, onlays
  • BONASIL A* Heavy (heavy normal set, heavy fast set) is to be used as a heavy body material for:
  • Two step putty/wash technique
  • Single step putty/wash technique
  • Functional peripheries
  • Crown/bridge work
  • Inlays, onlays
  • BONASIL A* Monophase (monophase normal set, monophase fast set) is to be used as a semi-heavy body material for:
  • Single step putty/wash technique
  • Functional peripheries
  • Crown/bridge work
  • Inlays, onlays
  • BONASIL A* Regular (regular normal set, regular fast set) is to be used as a medium body material for:
  • Two step putty/wash technique
  • Single step putty/wash technique
  • Functional peripheries
  • Reline impressions
  • Crown/bridge work
  • Inlays, onlays
  • BONASIL A* Light (light normal set, light fast set) is to be used as a light body material for:
  • Two step putty/wash technique
  • Single step putty/wash technique
  • Functional peripheries
  • Reline impressions
  • Crown/bridge work
  • Inlays, onlays
  • BONASIL A* Bonabite (bonabite fast set) is to be used as a light body material for:
  • Making accurate occlusal registrations
  • Standards bite registrations in the end bite position
  • Key material for needle point registration
  • Production of small model segments
  • An optical registration of occlusal data for CAD/CAM/CIM systems
  • BONASIL A* Alginate free (normal set, fast set) is an alternative to traditional alginate materials and is suitable for:
  • Preliminary impressions
  • Anatomic models
  • Fabricating temporary crowns and bridges
  • Opposing dentition
  • Fabricating simple removable prosthetic restorations
  • Orthodontic work
  • Case study models
AI/ML Overview

I'm sorry, but without further context, it is not possible to describe the acceptance criteria and the study that proves the device meets those criteria from the provided document. The document is an FDA 510(k) clearance letter for dental impression materials. It details the device name, intended use, and indications for use, but does not provide information about specific acceptance criteria or studies conducted to prove the device meets them.

§ 872.3660 Impression material.

(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).