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Device Explorer · FDA GUDID · GMDN 34713

Dental milling system, CAD/CAM, laboratory

An assembly of devices designed for automated computer-aided design (CAD) and computer-aided manufacturing (CAM) of custom-made (prescribed for one patient) dental restorations and/or orthodontic appliances (archwires) produced in the dental laboratory. It typ

US‑registered devices542in commercial distribution
Companies18labelers on GUDID
Single‑use13%of device records
Sterile0%labelled sterile
Prescription50%Rx‑only share
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Share of device records

Soadco, S.L.22041%
3Shape Trios A/S10519%
Medcad7313%
Zirkonzahn Srl5711%
Claronav Inc407%
Dentin Implants Technologies Ltd92%
Ulab Systems, Inc.71%
3Shape A/S61%

Top labelers

CompanyDevicesShare
Soadco, S.L.22041%
3Shape Trios A/S10519%
Medcad7313%
Zirkonzahn Srl5711%
Claronav Inc407%
Dentin Implants Technologies Ltd92%
Ulab Systems, Inc.71%
3Shape A/S61%
Kulzer Gmbh51%
Dental Wings Inc41%
Shining 3D Tech Co., Ltd.31%
Smart Optics Sensortechnik Gmbh31%

Company = labeler of record on GUDID. 18 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

MicronMapper EVOMicronMapperTissueMapperPROSTHETIC SCREWS3D SCANNINGOPERA SYSTEM®Adite®SHINING 3D®3Shape F83Shape Scan BodiesLab ScannerCubit360KAVO LS3InEos X5AccuPlan SystemuLab Systems uDesign

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

FDA product codes

CodeNameDevices
NOFSystem, Optical Impression, Computer Assisted Design And Man289
NDPAccessories, implant, dental, endosseous212
NDPAccessories, Implant, Dental, Endosseous119
LLZSystem, Image Processing, Radiological85
DZJDriver, Wire, And Bone Drill, Manual74
JEYPlate, Bone38

GMDN & GCC registration

  • GMDN code 34713 · non‑implantable
  • Single‑use 13% · sterile 0% · Rx‑only 50% · 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

Outer Diameter (Millimeter) · 92Length (Millimeter) · 42Width (Millimeter) · 3Height (Millimeter) · 3

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

How many dental milling system, cad/cam, laboratory products are registered in the US?

542 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental milling system, CAD/CAM, laboratory", from 18 companies. The largest labeler is Soadco, S.L. with 41% of records.

Which FDA product codes apply?

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

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.

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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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