FDA.reportPublic FDA data

OptraSculpt Starter Kit

Primary DI
DVIV683067AN1
Brand
OptraSculpt Starter Kit
Company
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Model
683067AN
Catalog number
683067AN
Device description
OptraSculpt Instrument, OptraSculpt Modelling tips
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
KXRAPPLICATOR, RESIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1
KXRApplicator, ResinDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
DVIV683067AN1PreviousHIBCC0
07615208294842PrimaryGS10
DIVO683067AN0Unit of UseHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07615208294842076152082948427615208294842

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
448015938
Device count
2
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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
10860013564701CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564718CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564725CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564732CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564756CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564763CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564770CurvaGc Orthodontics America Inc.DZN2026-05-28
07898488905190INSTRUMENT FOR ICERAM SLB BRACKETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
07908611211187CERAMIC NANO TUBE TWEEZERORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
07908611211255CURVERD SCISSORS FOR ALIGNERSORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
G149TBSB7500TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7510TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7520TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7530TBS BASICSACME ENTERPRISE.DZN2026-05-21
08404535018929Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535018950Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019049Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019070Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019131Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019162Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
07615208482430OptraSculptIVOCLAR VIVADENT AKTIENGESELLSCHAFTKXR2026-03-13
07615208482447OptraSculptIVOCLAR VIVADENT AKTIENGESELLSCHAFTKXR2026-03-13
07615208482751OptraSculptIVOCLAR VIVADENT AKTIENGESELLSCHAFTKXR2026-03-13
07615208294804OptraSculptIVOCLAR VIVADENT AKTIENGESELLSCHAFTKXR2026-01-15
07615208294828OptraSculptIVOCLAR VIVADENT AKTIENGESELLSCHAFTKXR2026-01-15
07615208294835OptraSculptIVOCLAR VIVADENT AKTIENGESELLSCHAFTKXR2026-01-15
07615208296747OptraSculptIVOCLAR VIVADENT AKTIENGESELLSCHAFTKXR2026-01-15
07615208296754OptraSculptIVOCLAR VIVADENT AKTIENGESELLSCHAFTKXR2026-01-15
07908854000647Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000654Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22