MetaSeal® S160

GUDID 00810000529476

MetaSeal® Endodontic Sealer Kit

PARKELL, INC.

Endodontic filling/sealing material

• Primary Device ID: 00810000529476
• NIH Device Record Key: 76d3879b-6ad1-41d7-98e4-4fa50c57b149
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MetaSeal®
• Version Model Number: S160
• Catalog Number: S160
• 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: false
• 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
• Phone: 6312491134
• Email: customerservice@parkell.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry location; Avoid excessive heat and moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry location; Avoid excessive heat and moisture

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810000529476 [Primary]

FDA Product Code

• KIF: Resin, Root Canal Filling

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-24
• Device Publish Date: 2018-11-23

On-Brand Devices [MetaSeal®]

• 00810000529490: MetaSeal® Powder 5gm
• 00810000529483: MetaSeal® Liquid 4.5ml
• 00810000529476: MetaSeal® Endodontic Sealer Kit
• 10810000529503: Scoops for MetaSeal® (Pkg. of 10 pcs.)