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Device Explorer · FDA GUDID · GMDN 38597

Dental milling system, CAD/CAM, chairside

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 produced chairside during dental or orthodontic treatment. It typically includes, o

US‑registered devices310in commercial distribution
Companies23labelers on GUDID
Single‑use4%of device records
Sterile0%labelled sterile
Prescription67%Rx‑only share
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Share of device records

Shining 3D Tech Co., Ltd.9230%
Align Technology, Inc.6621%
Shofu Dental Corporation3812%
Medit Corp.258%
3Shape Trios A/S237%
Sirona Dental Systems Gmbh103%
Carestream Health, Inc.103%
Carestream Dental Llc83%

Top labelers

CompanyDevicesShare
Shining 3D Tech Co., Ltd.9230%
Align Technology, Inc.6621%
Shofu Dental Corporation3812%
Medit Corp.258%
3Shape Trios A/S237%
Sirona Dental Systems Gmbh103%
Carestream Health, Inc.103%
Carestream Dental Llc83%
Exocad Gmbh62%
3M Company62%
Palodex Group Oy41%
Dental Wings Inc41%

Company = labeler of record on GUDID. 23 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SHINING 3D®cameo™SHINING3D®DENTSPLY SIRONA®Opera System®Zirkonzahn®MARATHON®ThunPure™LARGEV®cameo®xiujizhijia®Dentium®INTELLISCAN 3D® Intraoral ScannerSHINING 3D® Intraoral ScannerOPERA SYSTEM®ez2scan™

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 Man307
EBFMaterial, Tooth Shade, Resin38
NTKCaries Detector, Laser Light, Transmission33
NOFSystem, optical impression, computer assisted design and man22
PNPDental Abutment Design Software For Dental Laboratory10
NHAAbutment, Implant, Dental, Endosseous5

GMDN & GCC registration

  • GMDN code 38597 · non‑implantable
  • Single‑use 4% · sterile 0% · Rx‑only 67% · 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

Length (Meter) · 3Width (Millimeter) · 3Length (Millimeter) · 3Height (Millimeter) · 3Weight (Kilogram) · 2

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

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

310 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, chairside", from 23 companies. The largest labeler is Shining 3D Tech Co., Ltd. with 30% of records.

Which FDA product codes apply?

NOF (System, Optical Impression, Computer Assisted Design And Man), EBF (Material, Tooth Shade, Resin), NTK (Caries Detector, Laser Light, Transmission), NOF (System, optical impression, computer assisted design and man)

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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