BeautiLink SA C0207

GUDID 04548162320506

BeautiLink SA Automix syringe 2.5mL (4.4g) Ivory 1pc (SAMPLE)

SHOFU DENTAL CORPORATION

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin

• Primary Device ID: 04548162320506
• NIH Device Record Key: 3c3f88ca-13b2-4cb0-b0e2-6367e1e9fcf9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BeautiLink SA
• Version Model Number: C0207
• Catalog Number: C0207
• 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	04548162320506 [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