CompositeEtch 663103

GUDID D7796631030

COSMEDENT, INC.

Dental etching solution Dental etching solution

• Primary Device ID: D7796631030
• NIH Device Record Key: 35025c95-dac1-4833-893c-ecc4f1f776ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CompositeEtch
• Version Model Number: 663103
• Catalog Number: 663103
• 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	D7796631030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K910803

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: 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