Ena Etch ® COS101

GUDID EMICCOS1010

ENA-ETCH Etching gel 37% phosphoric acid 2ml

MICERIUM SPA

Dental etching solution

• Primary Device ID: EMICCOS1010
• NIH Device Record Key: 88a615fa-c4b6-49d9-9860-eb27c1f15c78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ena Etch ®
• Version Model Number: COS101
• Catalog Number: COS101
• 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: 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: false
• OTC Over-The-Counter: false

Device Dimensions

• Total Volume: 2 Milliliter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EMICCOS1010 [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: 2018-12-17
• Device Publish Date: 2018-11-16

On-Brand Devices [Ena Etch ®]

• EMICCOSM101B1: ENA-ETCH Etching gel 37% phosphoric acid Kit 2 x COS101 1 x COS101B
• EMICCOSM101A1: ENA-ETCH Etching gel 37% phosphoric acid Kit 4 x COS101 ENA-ETCH Etching gel 37% 2 ml
• EMICCOSM1011: ENA-ETCH Etching gel 37% phosphoric acid Kit 2 x COS101 ENA-ETCH Etching gel 37% 2 ml
• EMICCOS101B0: ENA-ETCH Etching gel 37% phosphoric acid 25ml
• EMICCOS1010: ENA-ETCH Etching gel 37% phosphoric acid 2ml