Ena Seal ® COSZ100

GUDID EMICCOSZ1001

ENA-SEAL light-curing sealant Kit 1 COSZ10 5 ml 1 COSM101 Ena -etch Etching gel 37% 2 ml

MICERIUM SPA

Dental unfilled resin sealant/coating

• Primary Device ID: EMICCOSZ1001
• NIH Device Record Key: 9883157b-007e-49b9-99bc-c611c8769a10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ena Seal ®
• Version Model Number: COSZ100
• Catalog Number: COSZ100
• Company DUNS: 436661136
• Company Name: MICERIUM SPA
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Total Volume: 7 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EMICCOSZ1001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072978

FDA Product Code

• DYH: Adhesive, Bracket And Tooth Conditioner, Resin

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: 2018-11-21

On-Brand Devices [Ena Seal ®]

• EMICCOSZ1020: ENA-SEAL light-curing sealant 2,5 ml
• EMICCOSZ101: ENA-SEAL light-curing sealant 5 ml
• EMICCOSZ1001: ENA-SEAL light-curing sealant Kit 1 COSZ10 5 ml 1 COSM101 Ena -etch Etching gel 37% 2 ml
• EMICCOSZ100: ENA-SEAL light-curing sealant 5 ml