Impressiv 70351P

GUDID D77970351P1

COSMEDENT, INC.

Silicone dental impression material

• Primary Device ID: D77970351P1
• NIH Device Record Key: bd7d8651-4266-4e77-a6a8-aff49b1b42d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Impressiv
• Version Model Number: 70351P
• Catalog Number: 70351P
• Company DUNS: 113911689
• Company Name: COSMEDENT, INC.
• Device Count: 2
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	D77970351P0 [Unit of Use]
HIBCC	D77970351P1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041229

FDA Product Code

• ELW: Material, Impression

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: 2016-09-22

On-Brand Devices [Impressiv]

• D779703MP21: 703MP2
• D779703LR21: 703LR2
• D77970351P1: 70351P