Silanator 602116

GUDID D7796021160

COSMEDENT, INC.

Dental prosthesis restorative material, unfilled resin

• Primary Device ID: D7796021160
• NIH Device Record Key: e77cf052-3959-4c45-bfb9-a06000f14257
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silanator
• Version Model Number: 602116
• Catalog Number: 602116
• 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	D7796021160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052501

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: 2016-09-22

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