EdgeSeal Root Canal Sealer

GUDID D858EESEAL04

EdgeSeal is a biocompatible root canal sealer for permanent sealing of root canals following established endodontic procedures and may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points).

EDGE ENDO LLC

Endodontic filling/sealing material

• Primary Device ID: D858EESEAL04
• NIH Device Record Key: 148d8abd-8db7-406b-a8f5-8958a2a206a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EdgeSeal Root Canal Sealer
• Version Model Number: EESEAL
• Company DUNS: 078474365
• Company Name: EDGE ENDO LLC
• 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

Device Dimensions

• Weight: 13.5 Gram
• Weight: 13.5 Gram

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D858EESEAL04 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-10-28

On-Brand Devices [EdgeSeal Root Canal Sealer]

• D858EESEAL1230: EdgeSeal is a biocompatible root canal sealer for permanent sealing of root canals following est
• D858EESEAL04: EdgeSeal is a biocompatible root canal sealer for permanent sealing of root canals following est
• 00818365020010: EdgeSeal is a biocompatible root canal sealer for permanent sealing of root canals following est