PRESS FORM KIT

Basic Information

• Brand Name: PRESS FORM KIT
• Primary DI: 00841494105129
• Version / Model: EPF172A
• Catalog Number: EPF172A
• Company Name: Cynosure, LLC
• Labeler DUNS: 780318028
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 52
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 4
• Public Version Date: 2023-01-11
• Public Version Status: Update
• Public Device Record Key: 1b800e3f-333f-44b9-adb6-1c83ce47b634

Device Description

PRESS FORM KIT, .020 SHEETS

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• 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
EBL	PIN, RETENTIVE AND SPLINTING, AND ACCESSORY INSTRUMENTS	Dental	872.3740	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31783	Temporary dental crown/bridge	A prosthetic dental device intended to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841494105129	GS1
Unit of Use	10841494105126	GS1