Faci Forms

Basic Information

• Brand Name: Faci Forms
• Primary DI: D798FFR0
• Version / Model: FFR
• Catalog Number: FFR
• Company Name: RELIANCE ORTHODONTIC PRODUCTS INC
• Labeler DUNS: 113170088
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-08
• Public Version: 3
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: 078026f0-0aa3-4db0-8dae-8a2a2d82c489

Device Description

Faci Forms are intended for use as a mold for creating temporary prosthetic composite teeth. These 5 medium and 5 large forms for the right side of the arch Size 22.

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: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ECP	Instrument, Ligature Tucking, Orthodontic	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38645	Dental veneer, professional	A custom-made dental restoration made of ceramic or polymer-based material (resin) intended to be used in aesthetic dentistry to correct the facial surface of a tooth; it is intended to be applied to the teeth by a dental professional for long-term use, typically via an adhesive. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D798FFR0	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in ambient conditions.