U.S. FDA Medical Device Precision Attachment Requirements
FDA Medical Device Definition: A precision attachment or preformed bar is a device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended for use in prosthetic dentistry in conjunction with removable partial dentures. Various forms of the device are intended to connect a lower partial denture with another lower partial denture, to connect an upper partial denture with another upper partial denture, to connect either an upper or lower partial denture to a tooth or a crown, or to connect a fixed bridge to a partial denture.
FDA Precision Attachment Establishment Registration
FDA Precision Attachment Listing
FDA Precision Attachment Label Requirements and Exceptions
FDA Precision Attachment Import Information
FDA Precision Attachment Detentions (Precision Attachment Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Precision Attachment Manufacturers (Precision Attachment Suppliers)
- Precision Attachment Distributors
- Precision Attachment Processors
- Precision Attachment Repackers
- Precision Attachment Relabelers
- Precision Attachment Exporters
- Precision Attachment Importers
For more information about Precision Attachment Medical Devices, simply click below:
U.S. FDA Regulations:
U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.
Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.