WAVE 8320001

GUDID DO3683200011

SDI LIMITED

Dental pit/fissure sealant

• Primary Device ID: DO3683200011
• NIH Device Record Key: 7e590134-f44f-4a15-875a-4aba13b50f1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WAVE
• Version Model Number: WAVE MV 20 COMP A1
• Catalog Number: 8320001
• Company DUNS: 753221852
• Company Name: SDI LIMITED
• Device Count: 20
• 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: +18002285166
• Email: info@sdi.com.au

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	DO3683200010 [Unit of Use]
HIBCC	DO3683200011 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-29

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