Set 8805003

GUDID 09336472018290

SET OA3 50 CAP

SDI LIMITED

Dental composite resin

• Primary Device ID: 09336472018290
• NIH Device Record Key: 96a467f9-8012-48a2-bfda-17066206d029
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Set
• Version Model Number: 8805003
• Catalog Number: 8805003
• Company DUNS: 753221852
• Company Name: SDI LIMITED
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *2°C - 8°C (36 - 46°F) Fridge storage
• Special Storage Condition, Specify: Between 0 and 0 *2°C - 8°C (36 - 46°F) Fridge storage
• Special Storage Condition, Specify: Between 0 and 0 *2°C - 8°C (36 - 46°F) Fridge storage
• Special Storage Condition, Specify: Between 0 and 0 *2°C - 8°C (36 - 46°F) Fridge storage
• Special Storage Condition, Specify: Between 0 and 0 *2°C - 8°C (36 - 46°F) Fridge storage
• Special Storage Condition, Specify: Between 0 and 0 *2°C - 8°C (36 - 46°F) Fridge storage
• Special Storage Condition, Specify: Between 0 and 0 *2°C - 8°C (36 - 46°F) Fridge storage
• Special Storage Condition, Specify: Between 0 and 0 *2°C - 8°C (36 - 46°F) Fridge storage
• Special Storage Condition, Specify: Between 0 and 0 *2°C - 8°C (36 - 46°F) Fridge storage
• Special Storage Condition, Specify: Between 0 and 0 *2°C - 8°C (36 - 46°F) Fridge storage
• Special Storage Condition, Specify: Between 0 and 0 *2°C - 8°C (36 - 46°F) Fridge storage
• Special Storage Condition, Specify: Between 0 and 0 *2°C - 8°C (36 - 46°F) Fridge storage
• Special Storage Condition, Specify: Between 0 and 0 *2°C - 8°C (36 - 46°F) Fridge storage

Device Identifiers

Device Issuing Agency	Device ID
GS1	09336472018290 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051008

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: 2025-01-16
• Device Publish Date: 2025-01-08

On-Brand Devices [Set]

• DO3688100001: SET ASSORTED KT
• DO3688050031: SET OA3 50 CAP
• DO3688050021: SET A2 50 CAP
• DO3688050011: SET A1 50 CAP
• 09336472018535: SET ASSORTED KT
• 09336472018290: SET OA3 50 CAP
• 09336472018283: SET A2 50 CAP
• 09336472018276: SET A1 50 CAP