SNAP™

Basic Information

• Brand Name: SNAP™
• Primary DI: 00810000527120
• Version / Model: S443
• Catalog Number: S443
• Company Name: PARKELL, INC.
• Labeler DUNS: 009900424
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-02
• Public Version: 4
• Public Version Date: 2023-01-11
• Public Version Status: Update
• Public Device Record Key: 67307469-b8fe-4f68-802c-60dd7a01b8fa
• Distribution End Date: 2021-12-08

Device Description

170gm SNAP™ Resin Shade 65

Device Characteristics

• Single Use: No
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EBG	Crown And Bridge, Temporary, Resin	Dental	872.3770	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45236	Temporary dental crown/bridge resin	A material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810000527120	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 25 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Store in a dry place, tightly sealed, away from direct light. Do not freeze. Use at room temperature. Do not store near eugenol containing materials. Polymer powder and liquid monomer are FLAMMABLE.