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Device Explorer · FDA GUDID · GMDN 16189

Dental casting wax

"A waxy dental material used to make patterns in the production of fixed dental prosthetic restorations by the ""lost-wax"" casting technique. After application, this device cannot be reused."

US‑registered devices296in commercial distribution
Companies15labelers on GUDID
Single‑use95%of device records
Sterile0%labelled sterile
Prescription67%Rx‑only share
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Share of device records

Institut Straumann Ag11037%
Mdc Dental8127%
Yamahachi Dental Mfg.,Co.6923%
Candulor Ag83%
Vita - Zahnfabrik H. Rauter Gesellschaft Mit Beschränkter Haftung & Co Kommanditgesellschaft52%
Cavex Holland B.V.52%
Aidite (Qinhuangdao) Technology Co., Ltd.41%
Paragon Implant Mfg., Llc31%

Top labelers

CompanyDevicesShare
Institut Straumann Ag11037%
Mdc Dental8127%
Yamahachi Dental Mfg.,Co.6923%
Candulor Ag83%
Vita - Zahnfabrik H. Rauter Gesellschaft Mit Beschränkter Haftung & Co Kommanditgesellschaft52%
Cavex Holland B.V.52%
Aidite (Qinhuangdao) Technology Co., Ltd.41%
Paragon Implant Mfg., Llc31%
3M Deutschland Gmbh21%
Preat Corporation21%
Shenzhen Yuechuan Trade Co., Ltd.21%
Dio Corporation21%

Company = labeler of record on GUDID. 15 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ROGSON WAX, MDC DentalAiditeCasting Wax ResinVITA VIONIC WAX3M™Cavex Set Up Hard Modelling Wax 2,5kgCavex Set Up Regular Modelling Wax 2,5kgCavex Set Up Hard Modelling WaxCavex Set Up Regular Modelling WaxCavex Set Up Soft Modelling WaxAESTHETIC WAXHaderMUA Plastic Lab. CopingMUA Burnout CopingPINSWAX DISK α

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

FDA product codes

CodeNameDevices
EGDWax, Dental, Intraoral168
NDPAccessories, implant, dental, endosseous98
EGDWAX, DENTAL, INTRAORAL17
DZEIMPLANT, ENDOSSEOUS, ROOT-FORM9
NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS7
NDPAccessories, Implant, Dental, Endosseous3

GMDN & GCC registration

  • GMDN code 16189 · non‑implantable
  • Single‑use 95% · sterile 0% · Rx‑only 67% · OTC 2%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Height (Millimeter) · 41Outer Diameter (Millimeter) · 26Angle (degree) · 15Length (Millimeter) · 3

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

How many dental casting wax products are registered in the US?

296 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental casting wax", from 15 companies. The largest labeler is Institut Straumann Ag with 37% of records.

Which FDA product codes apply?

EGD (Wax, Dental, Intraoral), NDP (Accessories, implant, dental, endosseous), EGD (WAX, DENTAL, INTRAORAL), DZE (IMPLANT, ENDOSSEOUS, ROOT-FORM)

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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