OptraSculpt 683068AN

GUDID 07615208445602

OptraSculpt Refill/ Ball/ 60

IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Dental restoration carver, resin

• Primary Device ID: 07615208445602
• NIH Device Record Key: 8090eadf-160e-4ef1-bd6d-19dde3396482
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptraSculpt
• Version Model Number: 683068AN
• Catalog Number: 683068AN
• Company DUNS: 448015938
• Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT
• Device Count: 60
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07615208294835 [Primary]
GS1	07615208445602 [Package]; Contains: 07615208294835; Package: [10 Units]; In Commercial Distribution
GS1	07615208472530 [Unit of Use]
HIBCC	DVIV683068AN1 [Previous]

FDA Product Code

• KXR: APPLICATOR, 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: 2026-01-23
• Device Publish Date: 2026-01-15

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