Denali Etching Gel DETCH3

GUDID D820DETCH30

Etching Gel, Dental.

DENALI CORPORATION

Dental etching solution Dental etching solution

• Primary Device ID: D820DETCH30
• NIH Device Record Key: 0d0ecda9-becc-4d8c-a46f-2a20002ced07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Denali Etching Gel
• Version Model Number: Syringe 3 mL
• Catalog Number: DETCH3
• Company DUNS: 191036107
• Company Name: DENALI CORPORATION
• 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

Customer Support Contacts

• Phone: +1-781-826-9190
• Email: denalicorp@denalicorporation.com
• Phone: +1-781-826-9190
• Email: denalicorp@denalicorporation.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D820DETCH30 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112597

FDA Product Code

• KLE: Agent, Tooth Bonding, Resin

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-05

On-Brand Devices [Denali Etching Gel]

• D820DETCH30: Etching Gel, Dental.
• D820DETCH120: Etching Gel, Dental.