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Device Explorer · FDA GUDID · GMDN 42344

Dental mould

A hollow form in which a dental material is intended to be injected, cast, or pressed to produce a particular shape.

US‑registered devices559in commercial distribution
Companies8labelers on GUDID
Single‑use97%of device records
Sterile0%labelled sterile
Prescription77%Rx‑only share
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Share of device records

Directa Ab20436%
Tdv Dental Ltda9617%
White Bite, Inc.8114%
Henry Schein, Inc.7013%
Darby Dental Supply, Llc417%
Reliance Orthodontic Products Inc356%
Ortho Arch Company Inc204%
Coltene/Whaledent Inc122%

Top labelers

CompanyDevicesShare
Directa Ab20436%
Tdv Dental Ltda9617%
White Bite, Inc.8114%
Henry Schein, Inc.7013%
Darby Dental Supply, Llc417%
Reliance Orthodontic Products Inc356%
Ortho Arch Company Inc204%
Coltene/Whaledent Inc122%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Darby Dental Supply, LLCWhite BiteORTHO ARCHPOSTERIOR MOLAR PADBUTTON BONDER TIPBUTTON BONDERWIRE BONDERReliaMoldA2RELIAMOLDSDISPOSABLE C&C PAD ATTACHMENT WITH CHAIN (1)DISPOSABLE C&C OVAL APPLICATOR WITHOUT CHAIN (1)RELIAMOLDDISPOSABLE C&C PAD APPLICATOR WITHOUT CHAIN (1)ParaPostDirecta FullForm

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

FDA product codes

CodeNameDevices
ELZCrown, Preformed300
DZNINSTRUMENTS, DENTAL HAND110
KCQTube Impression And Matrix82
DZCWire, Orthodontic34
ECQAligner, Bracket, Orthodontic14
DZNInstruments, Dental Hand12

GMDN & GCC registration

  • GMDN code 42344 · non‑implantable
  • Single‑use 97% · sterile 0% · Rx‑only 77% · 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 mould products are registered in the US?

559 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental mould", from 8 companies. The largest labeler is Directa Ab with 36% of records.

Which FDA product codes apply?

ELZ (Crown, Preformed), DZN (INSTRUMENTS, DENTAL HAND), KCQ (Tube Impression And Matrix), DZC (Wire, Orthodontic)

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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