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Device Explorer · FDA GUDID · GMDN 44999

Dental material mixing surface, chairside, single-use

A pad, tray, well, or palette with wells intended to be used as a surface for mixing inactive dental component materials chairside to produce a functional dental restorative/impression material that is immediately applied to the oral cavity/teeth of the patien

US‑registered devices58in commercial distribution
Companies11labelers on GUDID
Single‑use95%of device records
Sterile0%labelled sterile
Prescription16%Rx‑only share
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Share of device records

Reliance Orthodontic Products Inc1933%
Plasdent Corporation1322%
Jmu Dental, Inc712%
Premium Plus International Limited47%
Bisco Inc.47%
Ormco Corporation23%
Young Innovations, Inc.23%
Cargus International, Inc23%

Top labelers

CompanyDevicesShare
Reliance Orthodontic Products Inc1933%
Plasdent Corporation1322%
Jmu Dental, Inc712%
Premium Plus International Limited47%
Bisco Inc.47%
Ormco Corporation23%
Young Innovations, Inc.23%
Cargus International, Inc23%
Pulpdent Corporation23%
Gc America Inc.23%
Dynarex Corporation12%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

OrmcoPremium PlusPlasdentBONDWELLThe Orthodontic StoreRing WellsMIXING PADSMARK3MIXING RESERVOIR RING WELRELIABITE CHEWIE ALIGNER SEATER Y-SHAPED SOFTRELIABITE CHEWIE ALIGNER SEATER Y-SHAPED FIRMRELIABITE CHEWIE ALIGNER SEATER ROLLRELIAPRY ALIGNER REMOVAL TOOLLIGHT IMPERVIOUS MIX WELLCLEAR SCOOPWHITE MIXING WELL

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

FDA product codes

CodeNameDevices
NRDUnit, Operative Dental, Accessories15
KXRAPPLICATOR, RESIN12
JDZMixer, Cement, For Clinical Use10
PFLIntraoral, Dental Foam Protector10
ECPInstrument, Ligature Tucking, Orthodontic8
KXRApplicator, Resin6

GMDN & GCC registration

  • GMDN code 44999 · non‑implantable
  • Single‑use 95% · sterile 0% · Rx‑only 16% · 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 material mixing surface, chairside, single-use products are registered in the US?

58 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental material mixing surface, chairside, single-use", from 11 companies. The largest labeler is Reliance Orthodontic Products Inc with 33% of records.

Which FDA product codes apply?

NRD (Unit, Operative Dental, Accessories), KXR (APPLICATOR, RESIN), JDZ (Mixer, Cement, For Clinical Use), PFL (Intraoral, Dental Foam Protector)

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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