FDA.reportPublic FDA data

DTX Studio™ Lab

Primary DI
07332747173314
Brand
DTX Studio™ Lab
Company
Nobel Biocare AB
Model
1.11
Catalog number
300607
Device description
DTX Studio Lab 1.11 for Windows 64-bit
Published
2020-06-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PNPDental abutment design software for dental laboratory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNPDental Abutment Design Software For Dental LaboratoryDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181932000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181932000DTX Studio designNobel Biocare AB2019-03-01PNP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07332747173314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07332747173314073327471733147332747173314

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)322-5001us.customerservice@nobelbiocare.com

Regulatory Flags#

DUNS number
353939929
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07332747214918Nobel Biocare®3019313019312026-04-09
07332747214925Nobel Biocare®3019323019322026-04-09
07332747214932Nobel Biocare®3019333019332026-04-09
07332747214949Nobel Biocare®3019343019342026-04-09
07332747221510Nobel Biocare®3022543022542026-04-09
07332747221527Nobel Biocare®3022553022552026-04-09
07332747221534Nobel Biocare®3022563022562026-04-09
07332747223385Nobel Biocare®3022653022652026-04-09
07332747223392Nobel Biocare®3022643022642026-04-09
07332747223408Nobel Biocare®3022663022662026-04-09
07332747224436Nobel Biocare®3024853024852026-04-09
07332747224443Nobel Biocare®3024863024862026-04-09
07332747224450Nobel Biocare®3024883024882026-04-09
07332747224467Nobel Biocare®3024873024872026-04-09
07332747224474Nobel Biocare®3024893024892026-04-09
07332747224481Nobel Biocare®3024903024902026-04-09
07332747236620DTX Studio™ Clinic4.83008512026-03-27
07332747236637DTX Studio™ Clinic4.83008512026-03-27
07332747219616DTX Studio™ Clinic4.43008512025-01-26
07332747219623DTX Studio™ Clinic4.43008512025-01-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08435566602719IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30
08435566602764IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30
08435566601101IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-07-14
08435566609091IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609107IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609114IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609121IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609138IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609145IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609152IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609169IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609176IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609183IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609190IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609589IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609596IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609602IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609619IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609626IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609633IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609640IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566610691IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566610707IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566610714IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566610721IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566610776IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566610783IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566610790IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566610806IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566603839IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-16