Dental Impression Materials - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff

Description

This guidance document provides the FDA’s recommendations on performance criteria to support premarket submissions for dental impression materials in the Safety and Performance Based Pathway. Under this framework, submitters planning to submit a 510(k) using theSafety and Performance Based Pathwayfor dental impression materials will have the option to use the performance criteria proposed in this final guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device. The recommendations are intended to promote consistency and facilitate efficient review of dental impression materials.

Scope & Applicability

Regulatory Context

• 21CFR872.6570§ 872.6570 Impression tube.

  (a) Identification. An impression tube is a device consisting of a hollow copper tube intended to take an impression of a single tooth. The hollow tube is filled with impression material. One end of the tube is sealed with a softened material, such as wax, the remaining end is slipped over the toothRead full regulation →

• 21CFR872.6880§ 872.6880 Preformed impression tray.

  (a) Identification. A preformed impression tray is a metal or plastic device intended to hold impression material, such as alginate, to make an impression of a patient's teeth or alveolar process (bony tooth sockets) to reproduce the structure of a patient's teeth and gums.Read full regulation →

• 21CFR872.3670§ 872.3670 Resin impression tray material.

  (a) Identification. Resin impression tray material is a device intended for use in a two-step dental mold fabricating process. The device consists of a resin material, such as methyl methacrylate, and is used to form a custom impression tray for use in cases in which a preformed impression tray is nRead full regulation →

• 21CFR872.3661§ 872.3661 Optical Impression Systems for CAD/CAM.

  (a) Identification. An optical impression system for computer assisted design and manufacturing (CAD/CAM) is a device used to record the topographical characteristics of teeth, dental impressions, or stone models by analog or digital methods for use in the computer-assisted design and manufacturing Read full regulation →

• 21CFR872.3660§ 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 rRead full regulation →

• 21CFR10.115§ 10.115 Good guidance practices.

  (a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →

• Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" : Guidance for Industry and Food and Drug Administration Staff (Status: Final)
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