FDA.report

OptraSculpt Refill Kugel

Primary DI
DIVO683068AN0
Brand
OptraSculpt Refill Kugel
Company
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Model
683068AN
Catalog number
683068AN
Device description
OptraSculpt Refill
Published
2020-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
DZNINSTRUMENTS, DENTAL HAND

Product Code Classifications

CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
DIVO683068AN1PrimaryHIBCC0
DVIV683068AN1PrimaryHIBCC0
DIVO683068AN0Unit of UseHIBCC0

GMDN Terms

TermDefinition
Dental plastic restoration carverA hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in dental plastic restorations, e.g., for cutting, scraping, paring, and smoothing finishes and fashioning patterns (non-patient-contact). It will typically be a double-ended metal instrument with a solid blunt blade/nib of various sizes and designs with a central handle. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
448015938
Device count
60
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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06438311708720LMDentalLM-DentalDZN2026-03-23
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