OptraSculpt

Basic Information

• Brand Name: OptraSculpt
• Primary DI: 07615208296761
• Version / Model: 639791AN
• Catalog Number: 639791AN
• Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT
• Labeler DUNS: 448015938
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-07
• Public Version: 1
• Public Version Date: 2023-08-15
• Public Version Status: New
• Public Device Record Key: 5574962d-6067-4273-b721-19f10f39baf0

Device Description

OptraSculpt Pad Assortment

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KXR	APPLICATOR, RESIN	Dental	872.3140	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41861	Dental restoration carver, resin	A hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in dental composite or acrylic resin restorations, typically by cutting, scraping, paring, and smoothing finishes and modelling patterns intraorally. It will typically be a double-ended instrument with working ends of various shapes and designs, and a central handle. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07615208296761	GS1
Previous	DVIV639791AN1	HIBCC