Kwik 7031TA

GUDID D7797031TA0

COSMEDENT, INC.

Dental impression adhesive Dental impression adhesive Dental impression material adhesive Dental impression material adhesive Dental impression material adhesive Dental impression material adhesive Dental impression material adhesive Dental impression material adhesive Dental impression material adhesive Dental impression material adhesive Dental impression material adhesive Dental impression material adhesive Dental impression material adhesive Dental impression material adhesive Dental impression material adhesive Dental impression material adhesive

• Primary Device ID: D7797031TA0
• NIH Device Record Key: abbd43ea-fb22-4f4e-b51a-284ffb3b9777
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kwik
• Version Model Number: 7031TA
• Catalog Number: 7031TA
• Company DUNS: 113911689
• Company Name: COSMEDENT, INC.
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	D7797031TA0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992001

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

Devices Manufactured by COSMEDENT, INC.

• D7796722B01 - Bulkfill: 2022-03-16
• D7796722C31 - Bulkfill: 2022-03-16
• D7796722D21 - Bulkfill: 2022-03-16
• D7796722351 - Bulkfill: 2022-03-09
• D7796722A11 - Bulkfill: 2022-03-09
• D7796722A21 - Bulkfill: 2022-03-09
• D7796722A31 - Bulkfill: 2022-03-09
• D7796722B11 - Bulkfill: 2022-03-09