dental attachments

Basic Information

• Brand Name: dental attachments
• Primary DI: 08059224001517
• Version / Model: PARALLELOMETER KEY for OT BAR MULTIUSE
• Catalog Number: 028OCP
• Company Name: RHEIN 83 SRL
• Labeler DUNS: 439240722
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-28
• Public Version: 1
• Public Version Date: 2021-05-06
• Public Version Status: New
• Public Device Record Key: 50e40714-e129-401b-9b32-2d04690b13ca

Device Description

It's a metal device that serve to place the castable attachment on the master model in parallel using a parallelometer

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EGI	Parallelometer	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64322	Dental precision attachment fitting/adjustment tool	A manual dental laboratory instrument intended to be used in a dental laboratory during fabrication or revision of a final dental prosthesis (e.g., denture, crown, bridge) to integrate and/or adjust the fitting between male and female precision attachments. It is in the form of a handle with a distal end designed to perform a dedicated function (e.g., facilitate the parallel placement of a male attachment, remove/exchange/adjust an attachment, insert a retention insert, tighten a screwable element of an attachment); some types may be heated to enable melting, or attached to a motorized handpiece (e.g., drill). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08059224001517	GS1