CAD/CAM Software

CEREC SW 5.2 is dental CAD/CAM software for designing restorations from digital impressions. The software creates a virtual three-dimensional model, lets the user shape and edit a…

Registry build 21.09.26

CEREC SW 5.2 is dental CAD/CAM software for designing restorations from digital impressions. The software creates a virtual three-dimensional model, lets the user shape and edit a restoration, then supports the downstream milling workflow.

The filed license is the full primary education version. CEREC software supports designs such as crowns, veneers, inlays, onlays, bridges and abutment crowns, with tools selected for the restoration being prepared.

Listed Item

CEREC SW 5.2 Full version, Primary, EDU

Digital Design Workflow

CEREC SW moves from model preparation to restoration design and then to a production step such as milling. The 3D model allows the restoration geometry to be reviewed and adjusted before manufacture.

This is software, not the milling unit or scanner. The listed education license identifies a specific software entitlement and intended user context.

2manufacturers in China registered for this device type
9catalogue numbers in this listing

Who Else Makes It

All of them in Guangdong. 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code PNP
Manufacturer City Province Registered as Device types
Exceldent Dental Technology Development Co., Ltd. Zhuhai Guangdong Contract manufacturer 12
Shimmer Computerized Dental Technology Co., Ltd. Zhuhai Guangdong Contract manufacturer 10

Record

Regulatory record for CAD/CAM Software
Listed by Sirona Dental Systems Gmbh, Germany
FDA product code PNP
Device type Dental Abutment Design Software For Dental Laboratory
Device class Class 2
Regulation 21 CFR 872.3630
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Record published 2024-08-23
Record revised 2022-05-17 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for CAD/CAM Software
Catalogue number Size Status
6834639 In distribution
6853480 In distribution
6834670 In distribution
6834688 In distribution
6820893 In distribution
6834654 In distribution
6682228 In distribution
6823103 In distribution
6834647 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
IPD Implant Protesis Dental 2004 SL 317
BruxZir® Prismatik Dentalcraft, Inc. 62
Preat Preat Corporation 46
MEDENTiKA Medentika GmbH 36
Cerec Tessera Degudent Gmbh 15
BioHorizons Biohorizons Implant Systems Inc. 10
Nobel Biocare N1™ Nobel Biocare AB 10
Dental Abutment Design Software For Dental Laboratory Nobel Biocare AB 7
Cerec Degudent Gmbh 6
Preat Implant Prosthetics Preat Corporation 4
DTX Studio™ Lab Nobel Biocare AB 4
AbutmentCAD Exocad Gmbh 4

Showing 12 of 19. All products under Dental Abutment Design Software For Dental Laboratory

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer