FDA.reportPublic FDA data

OptraSculpt and OptraSculpt Pad System Kit

Primary DI
DVIV683066AN1
Brand
OptraSculpt and OptraSculpt Pad System Kit
Company
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Model
683066AN
Catalog number
683066AN
Device description
OptraSculpt Pad Instument, OptraSculpt Instrument, OptraSculpt Modelling tips, OptraSculpt Pad Modelling tips 4mm
Published
2020-08-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DZNINSTRUMENTS, DENTAL HAND

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
DVIV683066AN1PrimaryHIBCC0
DIVO683066AN0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental restoration carver, resinA 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.

Regulatory Flags#

DUNS number
448015938
Device count
4
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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