WAVE 8310102

GUDID 09336472013301

WAVE MV 1 SYR A1

SDI LIMITED

Dental composite resin

• Primary Device ID: 09336472013301
• NIH Device Record Key: 2adeddeb-4548-4660-8519-5a30936c70e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WAVE
• Version Model Number: 8310102
• Catalog Number: 8310102
• 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 10°C - 25°C (50 - 77°F) Recommended Cool Room Storage Do not refrigerate SDI composite products.
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions 10°C - 25°C (50 - 77°F) Recommended Cool Room Storage Do not refrigerate SDI composite products.
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions 10°C - 25°C (50 - 77°F) Recommended Cool Room Storage Do not refrigerate SDI composite products.
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions 10°C - 25°C (50 - 77°F) Recommended Cool Room Storage Do not refrigerate SDI composite products.
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions 10°C - 25°C (50 - 77°F) Recommended Cool Room Storage Do not refrigerate SDI composite products.
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions 10°C - 25°C (50 - 77°F) Recommended Cool Room Storage Do not refrigerate SDI composite products.
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions 10°C - 25°C (50 - 77°F) Recommended Cool Room Storage Do not refrigerate SDI composite products.
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions 10°C - 25°C (50 - 77°F) Recommended Cool Room Storage Do not refrigerate SDI composite products.
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions 10°C - 25°C (50 - 77°F) Recommended Cool Room Storage Do not refrigerate SDI composite products.
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions 10°C - 25°C (50 - 77°F) Recommended Cool Room Storage Do not refrigerate SDI composite products.
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions 10°C - 25°C (50 - 77°F) Recommended Cool Room Storage Do not refrigerate SDI composite products.
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions 10°C - 25°C (50 - 77°F) Recommended Cool Room Storage Do not refrigerate SDI composite products.
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions 10°C - 25°C (50 - 77°F) Recommended Cool Room Storage Do not refrigerate SDI composite products.

Device Identifiers

Device Issuing Agency	Device ID
GS1	09336472013301 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973091

FDA Product Code

• EBF: Material, tooth shade, resin

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 [WAVE]

• DO3683200031: WAVE MV 20 COMP A3
• DO3683200021: WAVE MV 20 COMP A2
• DO3683200011: WAVE MV 20 COMP A1
• DO3683141471: WAVE MV 1 SYR B
• DO3683122231: WAVE MV 1 SYR C2
• DO3683112111: WAVE MV 1 SYR B2
• DO3683111011: WAVE MV 1 SYR B1
• DO3683104051: WAVE MV 1 SYR A3.5
• DO3683103041: WAVE MV 1 SYR A3
• DO3683102041: WAVE MV 1 SYR OA2
• DO3683102031: WAVE MV 1 SYR A2
• DO3683101021: WAVE MV 1 SYR A1
• DO3683000001: WAVE MV INTRO KT
• DO3682141471: WAVE HV 1 SYR B
• DO3682122231: WAVE HV 1 SYR C2
• DO3682112111: WAVE HV 1 SYR B2
• DO3682111011: WAVE HV 1 SYR B1
• DO3682104051: WAVE HV 1 SYR A3.5
• DO3682103041: WAVE HV 1 SYR A3
• DO3682102041: WAVE HV 1 SYR OA2
• DO3682102031: WAVE HV 1 SYR A2
• DO3682101021: WAVE HV 1 SYR A1
• DO3682000001: WAVE HV INTRO KT
• DO3675200041: WAVE 20 COMP A3.5
• DO3675200031: WAVE 20 COMP A3
• DO3675200021: WAVE 20 COMP A2
• DO3675200011: WAVE 20 COMP A1
• DO3675141471: WAVE 1 SYR B
• DO3675141431: WAVE 1 SYR G
• DO3675141421: WAVE 1 SYR I
• DO3675133341: WAVE 1 SYR D3
• DO3675123241: WAVE 1 SYR C3
• DO3675122231: WAVE 1 SYR C2
• DO3675113141: WAVE 1 SYR B3
• DO3675112111: WAVE 1 SYR B2
• DO3675111011: WAVE 1 SYR B1
• DO3675104051: WAVE 1 SYR A3.5
• DO3675103041: WAVE 1 SYR A3
• DO3675102041: WAVE 1 SYR OA2
• DO3675102031: WAVE 1 SYR A2
• DO3675101021: WAVE 1 SYR A1
• DO3675000131: WAVE BULK KT A3
• DO3675000121: WAVE BULK KT A2
• DO3675000111: WAVE BULK KT A1
• DO3675000001: WAVE INTRO KT
• 09336472013530: WAVE MV 20 COMP A2
• 09336472013356: WAVE MV 1 SYR B1
• 09336472013349: WAVE MV 1 SYR A3.5
• 09336472013325: WAVE MV 1 SYR OA2
• 09336472013318: WAVE MV 1 SYR A2