OptraSculpt 759593AN

GUDID 07615208482416

OptraSculpt Pad Instrument Refill

IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Dental restoration carver, resin

• Primary Device ID: 07615208482416
• NIH Device Record Key: 5635eb6b-8439-483b-88a8-037342d8a683
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptraSculpt
• Version Model Number: 759593AN
• Catalog Number: 759593AN
• 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	07615208482416 [Primary]

FDA Product Code

• KXR: APPLICATOR, RESIN

Sterilization

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

[07615208482416]

Moist Heat or Steam Sterilization

[07615208482416]

Moist Heat or Steam Sterilization

[07615208482416]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-23
• Device Publish Date: 2026-03-13

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