FDA.reportPublic FDA data

OptraSculpt Pad Refill

Primary DI
DIVO639792AN0
Brand
OptraSculpt Pad Refill
Company
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Model
639792AN
Catalog number
639792AN
Device description
OptraSculpt Pad 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

Product Codes#

Code, Name table
CodeName
KXRAPPLICATOR, RESIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXRApplicator, ResinDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
DVIV639792AN2PackageHIBCC10In Commercial Distribution
DIVO639792AN1PrimaryHIBCC0
DVIV639792AN1PrimaryHIBCC0
DIVO639792AN0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
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 table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07615208592580IPS e.max Ceram Art7728287728282026-05-04
07615208592597IPS e.max Ceram Art7728297728292026-05-04
07615208482775ProBase Hot / ProBase Cold7641287641282026-04-30
07615208291643OptraGloss742102WW742102WW2026-04-23
07615208295917Variolink Esthetic Try-In666115WW666115WW2026-04-20
07615208482706Variolink Esthetic Try-In762063WW762063WW2026-04-20
07615208539189IPS e.max Zirconia7642737642732026-03-26
07615208539677IPS e.max Zirconia7642817642812026-03-26
07615208539684IPS e.max Zirconia7642937642932026-03-26
07615208539691IPS e.max Zirconia7643017643012026-03-26
07615208539707IPS e.max Zirconia7643137643132026-03-26
07615208539714IPS e.max Zirconia7643217643212026-03-26
07615208539721IPS e.max Zirconia7643337643332026-03-26
07615208539738IPS e.max Zirconia7643417643412026-03-26
07615208539745IPS e.max Zirconia7643537643532026-03-26
07615208540055IPS e.max Zirconia7643617643612026-03-26
07615208540062IPS e.max Zirconia7643737643732026-03-26
07615208540079IPS e.max Zirconia7643817643812026-03-26
07615208540086IPS e.max Zirconia7643937643932026-03-26
07615208542301IPS e.max Zirconia7642747642742026-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D1257500B2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257500G2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257500L2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257500Y2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257501B2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257501G2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257501L2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257501Y2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257502T4Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257502W4Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257510B2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257510G2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257510L2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257510Y2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257511B2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257511G2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257511L2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257511Y2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125902D2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125902TLG1002Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125903B2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125903D2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125903T2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125903TLL1002Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125904B2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125904D2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125904T2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125904TWT1002Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125921B2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125921G2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21