Device Explorer · FDA GUDID · GMDN 50484

CAD/CAM software

A 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 plannin

US‑registered devices242in commercial distribution
Companies31labelers on GUDID
Single‑use2%of device records
Sterile0%labelled sterile
Prescription85%Rx‑only share
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Share of device records

Sirona Dental Systems Gmbh11246%
Materialise Nv6426%
3Diemme Srl94%
Disior Oy52%
3Shape A/S52%
Medit Corp.52%
Zetta25 Ag42%
Dentca, Inc.42%

Top labelers

CompanyDevicesShare
Sirona Dental Systems Gmbh11246%
Materialise Nv6426%
3Diemme Srl94%
Disior Oy52%
3Shape A/S52%
Medit Corp.52%
Zetta25 Ag42%
Dentca, Inc.42%
Prismatik Dentalcraft, Inc42%
Nobel Biocare Ab31%
Progressive America, Inc.31%
Orametrix, Inc.31%

Company = labeler of record on GUDID. 31 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

HOFFMANNDTX Studio™ LabAngel AlignerSHINING 3D®BonelogicSMART PCFDSMART Bun-Yo-Matic™ XraySMART Bun-Yo-Matic™ CTAutomateDental SystemAbutment DesignAnatomy DesignSurgiCase PlannerMimics Automatic AlgorithmsMimics Cardiac PlannerProPlan CMF

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
LLZSystem, Image Processing, Radiological72
NDPAccessories, Implant, Dental, Endosseous67
NOFSystem, Optical Impression, Computer Assisted Design And Man30
NHAAbutment, Implant, Dental, Endosseous29
PNNOrthodontic Software21
PNPDental abutment design software for dental laboratory18

GMDN & GCC registration

  • GMDN code 50484 · non‑implantable
  • Single‑use 2% · sterile 0% · Rx‑only 85% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

How many cad/cam software products are registered in the US?

242 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "CAD/CAM software", from 31 companies. The largest labeler is Sirona Dental Systems Gmbh with 46% of records.

Which FDA product codes apply?

LLZ (System, Image Processing, Radiological), NDP (Accessories, Implant, Dental, Endosseous), NOF (System, Optical Impression, Computer Assisted Design And Man), NHA (Abutment, Implant, Dental, Endosseous)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

How do I get quotes?

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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