OptraSculpt 646004AN

GUDID 07615208433869

OptraSculpt Pad Instrument Refill

IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Dental restoration carver, resin

• Primary Device ID: 07615208433869
• NIH Device Record Key: 42ac03e7-aaf9-44e8-ba82-ab9f4e3bb995
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptraSculpt
• Version Model Number: 646004AN
• Catalog Number: 646004AN
• Company DUNS: 448015938
• Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07615208296303 [Primary]
GS1	07615208433869 [Direct Marking]

FDA Product Code

• DZN: INSTRUMENTS, DENTAL HAND

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[07615208433869]

Moist Heat or Steam Sterilization

[07615208433869]

Moist Heat or Steam Sterilization

[07615208433869]

Moist Heat or Steam Sterilization

[07615208433869]

Moist Heat or Steam Sterilization

[07615208433869]

Moist Heat or Steam Sterilization

[07615208433869]

Moist Heat or Steam Sterilization

[07615208433869]

Moist Heat or Steam Sterilization

[07615208433869]

Moist Heat or Steam Sterilization

[07615208433869]

Moist Heat or Steam Sterilization

[07615208433869]

Moist Heat or Steam Sterilization

[07615208433869]

Moist Heat or Steam Sterilization

[07615208433869]

Moist Heat or Steam Sterilization

[07615208433869]

Moist Heat or Steam Sterilization

[07615208433869]

Moist Heat or Steam Sterilization

[07615208433869]

Moist Heat or Steam Sterilization

[07615208433869]

Moist Heat or Steam Sterilization

[07615208433869]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-15
• Device Publish Date: 2023-08-07

On-Brand Devices [OptraSculpt]

• DIVO590757AN1: OptraSculpt double sided Ref.
• 07615208296761: OptraSculpt Pad Assortment
• 07615208433869: OptraSculpt Pad Instrument Refill
• 07615208294859: OptraSculpt & OptraSculpt Pad System Kit
• DVIV683067AN1: OptraSculpt Starter Kit
• 07615208445947: OptraSculpt Pad Refill/4 mm/60
• 07615208486254: OptraSculpt Pad Refill/6 mm/60
• 07615208445602: OptraSculpt Refill/ Ball/ 60
• 07615208445596: OptraSculpt Refill/ Chisel/ 60
• 07615208488401: OptraSculpt Refill/ Pointed Tip/ 60