FDA.reportPublic FDA data

DS Core Resto

Primary DI
04262352354897
Brand
DS Core Resto
Company
Zetta25 AG
Model
04262352354897
Published
2026-08-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
NOFSystem, optical impression, computer assisted design and manufacturing (cad/cam) of dental restorations

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental RestorationsDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04262352354897PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04262352354897042623523548974262352354897

GMDN Terms#

Term, Definition table
TermDefinition
CAD/CAM softwareA software program intended to provide computer-aided design (CAD) or computer-aided manufacturing (CAM) functionality for the production of patient-specific custom-made devices (e.g., orthopaedic implants, dental devices, anatomical models), treatment planning, simulation, and/or robotic capabilities for device production (e.g., 3-D printing). It may include functionality to upload patient-specific images and to facilitate communication between healthcare professionals.

Regulatory Flags#

DUNS number
480534923
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
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
04262352357935DS Core Detect04262352357935S38512026-06-03
04262352351605DS Core Diagnosis04262352351605S38092026-04-30
04262352350042DS Core Resto04262352350042S38172025-09-09
04262352350035DI Scan04262352350035S38062025-02-21
04262352353517DS Core Diagnosis04262352353517S38092025-09-05
04262352359243DI Scan042623523592432024-04-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975456120005UP3D Intraoral ScannerShenzhen UP3d Technology Co., Ltd.NOF2026-08-19
00693856000340DEXIS Imprevo SLIM TIPDental Imaging Technologies CorporationNOF2026-08-07
06942799000820Marathon®Shining 3D Tech Co., Ltd.NOF2026-07-30
06942799000837Marathon®Shining 3D Tech Co., Ltd.NOF2026-07-30
06942799000844Marathon®Shining 3D Tech Co., Ltd.NOF2026-07-30
06942799000851Marathon®Shining 3D Tech Co., Ltd.NOF2026-07-30
06970163088693SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-07-21
08800019601081LS-100-TIPHuvitz Co., Ltd.NOF2026-07-17
08800019601128LSO-100-TIPHuvitz Co., Ltd.NOF2026-07-17
08800019601135LSO-100-TIPHuvitz Co., Ltd.NOF2026-07-17
06430035421077Planmeca OnyxPlanmeca OyNOF2026-06-24
06970163089140SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-05-20
06975456126007UP3D Intraoral ScannerShenzhen UP3d Technology Co., Ltd.NOF2026-05-18
06970163084022SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-05-11
06970163084039SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-05-11
06970163084046SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-05-11
08800026700760Medit Link ExpressMedit Corp.NOF2026-04-28
08800026700883Medit Link ExpressMedit Corp.NOF2026-04-28
06973993442499Intraoral ScannerAlliedstar Medical Equipment Co., Ltd.NOF2026-04-20
00810060227053Blue Sky Bio, LLC.BLUE SKY BIO LLCNOF2026-04-13
06970163089966SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-03-23
06970163089973SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-03-23
06970163089836SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-03-16
D745701181MIL001610150fastdesign.ioPrismatik Dentalcraft, IncNOF2026-03-16
D745701181MIL046710150fastdesign.ioPrismatik Dentalcraft, IncNOF2026-03-16
07540209957482MicronMapperClaronav IncNOF2026-02-10
07540209957499MicronMapperClaronav IncNOF2026-02-10
07540209957505MicronMapperClaronav IncNOF2026-02-10
07540209957512MicronMapperClaronav IncNOF2026-02-10
07540209957529MicronMapperClaronav IncNOF2026-02-10