Cinch™ S463S

GUDID M595S463S1

Quick Cinch™ Heavy Body in Split-Cartridge System (4-Cartridges & Mixing Tips)

PARKELL, INC.

Silicone dental impression material

• Primary Device ID: M595S463S1
• NIH Device Record Key: 50e333f4-2744-4bbb-a899-17c9ee57a4f7
• Commercial Distribution Discontinuation: 2019-01-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Cinch™
• Version Model Number: S463S
• Catalog Number: S463S
• Company DUNS: 009900424
• Company Name: PARKELL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 6312491134
• Email: customerservice@parkell.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 75 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M595S463S0 [Primary]
HIBCC	M595S463S1 [Package]; Contains: M595S463S0; Package: [4 Units]; Discontinued: 2019-01-01; Not in Commercial Distribution

FDA Product Code

• ELW: Material, Impression

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-04-01
• Device Publish Date: 2016-09-23

On-Brand Devices [Cinch™]

• 00810000524099: Cinch™ Platinum Super Cartridge 380ml
• 00810000524082: Quick Cinch™ Heavy Body Super Cartridge 380ml
• 00810000524075: 380ml. Super-Size Cartridge Cinch™ 90 Medium-Body (For Pentamix Dispensers)
• M595S4640: 380ml. Super-Size Cartridge Cinch™ 90 Medium-Body (For Pentamix Dispensers)
• M595S463S1: Quick Cinch™ Heavy Body in Split-Cartridge System (4-Cartridges & Mixing Tips)
• M595S461S1: Quick Cinch™ Light-Body in Split-Cartridge System (4-Cartridges & Mixing Tips)
• M595S460S1: Cinch™ Light Split-Cartridge System (4-Cartridges & Mixing Tips)
• M595S456S1: Cinch™ Putty Split-Cartridge System (4-Cartridges & Tips)
• M595S454S1: Cinch™ Platinum Medium Body In Split-Cartridge No Clog Auto Mix System (4-Cartridges & Tips)
• M595S453S1: Cinch™ 90 Medium-Body Split-Cartridge System (4-Cartridges & Tips)
• M595S4351: Cinch™ Platinum Tubes (Contains: 2-Tubes Base & 2-Tubes Catalyst)
• 10810000524065: Quick Cinch™ Heavy Body in Split-Cartridge System (4-Cartridges & Mixing Tips)
• 10810000524058: Quick Cinch™ Light-Body in Split-Cartridge System (4-Cartridges & Mixing Tips)
• 10810000524041: Cinch™ Light Split-Cartridge System (4-Cartridges & Mixing Tips)
• 10810000524034: Cinch™ Putty Split-Cartridge System (4-Cartridges & Tips)
• 10810000524027: Cinch™ Platinum Medium Body In Split-Cartridge System (4-Cartridges & Tips)
• 10810000524010: Cinch™ 90 Medium Body in Split-Cartridge System (4-Cartridges & Tips)
• 10810000524003: Cinch™-Platinum Tubes (Contains: 2-Tubes Base & 2-Tubes Cata
• 10810000527004: 5:1 Yellow Dynamic Mixing Tip for 380ml Super-Size Cartridge (Pkg. of 50 pcs.)
• 10810000524416: Quick Cinch® Plus Ultra-Light Wash (2-Cartridges & Tips)
• 10810000524409: Cinch® Plus Ultra-Light Wash (2-Cartridges & Tips)