Consulting Wallah › Device Explorer › Dental › Dental treatment application software
Device Explorer · FDA GUDID · GMDN 60883

Dental treatment application software

An application software program intended to facilitate dental treatment, which may include dental implant and/or oral/maxillofacial surgery planning, by storing/displaying patient demographics/clinical data and treatment plans, and may control settings for den

US‑registered devices59in commercial distribution
Companies18labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription93%Rx‑only share
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Share of device records

Nobel Biocare Ab1831%
Swissmeda Ag814%
3Shape A/S58%
Blue Sky Bio Llc58%
Zirkonzahn Srl47%
Exocad Gmbh35%
Software Nemotec Sl35%
Patterson Dental Supply, Inc.23%

Top labelers

CompanyDevicesShare
Nobel Biocare Ab1831%
Swissmeda Ag814%
3Shape A/S58%
Blue Sky Bio Llc58%
Zirkonzahn Srl47%
Exocad Gmbh35%
Software Nemotec Sl35%
Patterson Dental Supply, Inc.23%
3D Industrial Imaging Co.,Ltd23%
Guidepro3D12%
Xnav Technologies Llc12%
Carestream Dental Llc12%

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

Brand names on the register (sample)

IPS CaseDesigner®DTX Studio™ ImplantIPS CaseDesigner™Implant StudioAutomateSplint DesignOrtho SystemexoplanGuidePro3DZIRKONZAHN.Implant-Planner Practice incl. Bone &ZIRKONZAHN.Implant-Planner incl. Bone & Tooth SeZIRKONZAHN.Implant-Planner PracticeZIRKONZAHN.Implant-PlannerX-GuideBlue Sky Bio, LLC.Dolphin Imaging 12.0

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, Radiological44
LLZSystem, image processing, radiological32
PNNOrthodontic Software10
NOFSystem, Optical Impression, Computer Assisted Design And Man5
NXCAligner, Sequential4
PZYAdditively Manufactured, Preformed, Resin Denture Tooth4

GMDN & GCC registration

  • GMDN code 60883 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 93% · 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 dental treatment application software products are registered in the US?

59 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental treatment application software", from 18 companies. The largest labeler is Nobel Biocare Ab with 31% of records.

Which FDA product codes apply?

LLZ (System, Image Processing, Radiological), LLZ (System, image processing, radiological), PNN (Orthodontic Software), 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.

How do I get quotes?

Add dental treatment application software to the RFQ basket or use the form below with quantity, specification and delivery location; the Network returns comparable quotes from verified suppliers in 2–5 working days.

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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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