ANSI ADA Standard No. 53 - 2008 (Reaffirmed 2013)

Polymer-Based Crown And Bridge Materials

Standard No. 53 - 2008 (Reaffirmed 2013)

Standard Organization: ANSI ADA

ANSI ADA Standard No. 53 - 2008 (Reaffirmed 2013)
Polymer-Based Crown and Bridge Materials

Recognition NumberDental/ENT
Recognition Date2018-06-07
Recognition List049
Recognition Number4-89
Extent Complete standard
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STG Dental/ENT
FDA Tech  Michael Adjodha   FDA/OMPT/CDRH/ODE/DAGID/DEDB   301-796-6276   michael.adjodha@fda.hhs.gov

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

This standard classifies polymer-based dental crown and bridge materials and specifies their requirements. It also specifies the test methods to be used to determine compliance with these requirements. This standard is applicable to polymer-based dental crown and bridge materials for laboratory-fabricated permanent facings or anterior crowns that may or may not be attached to a metal substructure. It also applies to polymer-based dental crown and bridge materials for which the manufacturer claims adhesion to the metal substructure without macromechanical retention such as beads or wires.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§872.3770 Crown And Bridge, Temporary, Resin Class 2 EBG
§872.3690 Material, Tooth Shade, Resin Class 2 EBF

FDA Guidance:

Guidance for Industry and FDA Staff: Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions, Issued October 2005.

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