BeautiLink SA C0205

GUDID 04548162300829

BeautiLink SA Automix syringe 5mL (8.6g) Opaque 1pc

SHOFU DENTAL CORPORATION

Dental composite resin

• Primary Device ID: 04548162300829
• NIH Device Record Key: d0875b62-2fb9-487f-a0e7-c85cca8569de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BeautiLink SA
• Version Model Number: C0205
• Catalog Number: C0205
• Company DUNS: 054618202
• Company Name: SHOFU DENTAL 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: true
• 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

Customer Support Contacts

• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com
• Phone: 760-736-3277
• Email: customer-service@shofu.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04548162300829 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233161

FDA Product Code

• EMA: Cement, Dental

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-31
• Device Publish Date: 2023-10-23

On-Brand Devices [BeautiLink SA]

• 84548162300825: BeautiLink SA Automix syringe 5mL (8.6g) Opaque 2pcs
• 84548162300818: BeautiLink SA Automix syringe 5mL (8.6g) Ivory 2pcs
• 84548162300801: BeautiLink SA Automix syringe 5mL (8.6g) Clear 2pcs
• 84548162300795: BeautiLink SA Handmix syringe 9mL (15.6g) Opaque 2pcs
• 84548162300788: BeautiLink SA Handmix syringe 9mL (15.6g) Ivory 2pcs
• 84548162300771: BeautiLink SA Handmix syringe 9mL (15.6g) Clear 2pcs
• 04548162320513: BeautiLink SA Automix syringe 2.5mL (4.4g) Opaque 1pc (SAMPLE)
• 04548162320506: BeautiLink SA Automix syringe 2.5mL (4.4g) Ivory 1pc (SAMPLE)
• 04548162320490: BeautiLink SA Automix syringe 2.5mL (4.4g) Clear 1pc (SAMPLE)
• 04548162300829: BeautiLink SA Automix syringe 5mL (8.6g) Opaque 1pc
• 04548162300812: BeautiLink SA Automix syringe 5mL (8.6g) Ivory 1pc
• 04548162300805: BeautiLink SA Automix syringe 5mL (8.6g) Clear 1pc
• 04548162300799: BeautiLink SA Handmix syringe 9mL (15.6g) Opaque 1pc
• 04548162300782: BeautiLink SA Handmix syringe 9mL (15.6g) Ivory 1pc
• 04548162300775: BeautiLink SA Handmix syringe 9mL (15.6g) Clear 1pc