EdgeCaOH Calcium Hydroxide Root Canal Filling Material

GUDID D858EECAOH1230

For use, as a temporary root canal filling after endodontic surgery. Metapaste can be used on its own and for vital pulpdectomies in decidious teeth.

EDGE ENDO LLC

Endodontic filling/sealing material

• Primary Device ID: D858EECAOH1230
• NIH Device Record Key: 1b21d54a-46e4-4c2c-8b67-0ef19a943f1d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EdgeCaOH Calcium Hydroxide Root Canal Filling Material
• Version Model Number: EECAOH
• 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: 2.2 Gram
• Weight: 2.2 Gram

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D858EECAOH1230 [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: 2017-01-21

On-Brand Devices [EdgeCaOH Calcium Hydroxide Root Canal Filling Material]

• D858EECAOH1230: For use, as a temporary root canal filling after endodontic surgery. Metapaste can be used on it
• D858EECAOH0: For use, as a temporary root canal filling after endodontic surgery. Metapaste can be used on it
• 00818365020003: For use, as a temporary root canal filling after endodontic surgery. Metapaste can be used on it