FDA.reportPublic FDA data

CAD/CAM Software

Primary DI
E27668534800
Brand
CAD/CAM Software
Company
SIRONA Dental Systems GmbH
Model
6853480
Device description
CEREC SW 5.2 Full version, Primary, EDU
Published
2025-08-19
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
NDPAccessories, implant, dental, endosseous
NHAAbutment, implant, dental, endosseous
PNPDental abutment design software for dental laboratory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1
NHAAbutment, Implant, Dental, EndosseousDental2
PNPDental Abutment Design Software For Dental LaboratoryDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E27668534800PrimaryHIBCC0

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
+4962511670contact@dentsplysirona.com

Regulatory Flags#

DUNS number
340306351
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E27668907712Single use sleeve Primescan Box68907712026-09-22
E27667732580Sidexis 467732582022-12-20
E27667737871Sidexis 467737872022-12-20
E27667755841Sidexis 467755842022-12-20
E27667755921Sidexis 467755922022-12-20
E27666182630Sidexis 466182632021-12-23
E27662291290SIDEXIS XG62291292016-09-10
E27664565320SIDEXIS 464565322016-09-10
E27666164650Sidexis 466164652017-04-20
E27666632770Sidexis 466632772018-08-27
E27668234260Primevision 3D682342667585982026-02-13
E27668234830Primevision 3D68234832026-04-30
E27668665320Midwest IMPLANT 20:168665322026-02-19
E27668312130Midwest Motor Control Module683121368312132026-02-17
E27668302980Midwest Power Lux Implant Motor683029868302982026-02-13
E27668303060Midwest Power Lux Motor683030668303062026-02-13
E27660437020IMPLANT 20:160437022016-09-10
E27668082030Primescan 268082032025-11-21
E27668325910TiBase683259168325912025-10-28
E27668326410TiBase683264168326412025-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290109748344Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07290109748351Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07899878068181NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068198NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068211NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068228NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068235NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068242NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068259NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068266NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068273NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068280NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068297NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
D955BBCG35450Paul BandittTerlain Enterprises, Inc.NDP2026-09-25
07392532070303Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070310Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070327Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070334Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070341Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070358Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070365Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070372Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070389Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070396Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070402Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532037399Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-11-10
07392532000966Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000973Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000997Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001529Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14