Set PP 8805103

GUDID 09336472018399

SET PP OA3 SYR 2 PK

SDI LIMITED

Dental composite resin

• Primary Device ID: 09336472018399
• NIH Device Record Key: 43b0ecf4-fe7a-4fad-bc5e-9a7e9457a414
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Set PP
• Version Model Number: 8805103
• Catalog Number: 8805103
• 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 *Storage conditions 2°C - 25°C (36 - 77°F) Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions 2°C - 25°C (36 - 77°F) Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions 2°C - 25°C (36 - 77°F) Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions 2°C - 25°C (36 - 77°F) Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions 2°C - 25°C (36 - 77°F) Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions 2°C - 25°C (36 - 77°F) Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions 2°C - 25°C (36 - 77°F) Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions 2°C - 25°C (36 - 77°F) Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions 2°C - 25°C (36 - 77°F) Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions 2°C - 25°C (36 - 77°F) Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions 2°C - 25°C (36 - 77°F) Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions 2°C - 25°C (36 - 77°F) Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions 2°C - 25°C (36 - 77°F) Storage conditions < 25°C (< 77°F)

Device Identifiers

Device Issuing Agency	Device ID
GS1	09336472018399 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073043

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 PP]

• DO3688100061: SET PP ENDO TIPS
• DO3688100051: SET PP INTRA-ORAL TIPS
• DO3688100041: SET PP MIXING TIPS (WIDE)
• DO3688100031: SET PP MIXING TIPS (REGULAR)
• DO3688100021: SET PP ASSTD 5 SYR
• DO3688051051: SET PP TRANSLUCENT SYR 2 PK
• DO3688051041: SET PP WHT/OPQ SYR 2 PK
• DO3688051031: SET PP OA3 SYR 2 PK
• DO3688051021: SET PP A2 SYR 2 PK
• DO3688051011: SET PP A1 SYR 2 PK
• 09336472018597: SET PP ENDO TIPS (10 Pack)
• 09336472018573: SET PP MIXING TIPS (WIDE) (10 Pack)
• 09336472018566: SET PP MIXING TIPS (REGULAR) (50 Pack)
• 09336472018559: SET PP ASSTD 5 SYR
• 09336472018412: SET PP TRANSLUCENT SYR 2 PK
• 09336472018405: SET PP WHT/OPQ SYR 2 PK
• 09336472018399: SET PP OA3 SYR 2 PK
• 09336472018382: SET PP A2 SYR 2 PK
• 09336472018375: SET PP A1 SYR 2 PK
• 09336472018580: SET PP INTRA-ORAL TIPS (10)