Consulting Wallah › Device Explorer › Dental › Dental material mixing surface, chairside, reusabl
Device Explorer · FDA GUDID · GMDN 63877

Dental material mixing surface, chairside, reusable

A slab, tray, or 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 pa

US‑registered devices53in commercial distribution
Companies11labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription8%Rx‑only share
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Share of device records

Plasdent Corporation2547%
Premium Plus International Limited1223%
Jmu Dental, Inc48%
Pulpdent Corporation48%
Parkell, Inc.24%
Peter Brasseler Holdings, Llc12%
A. Titan Instruments, Inc.12%
Salvin Dental Specialties, Llc12%

Top labelers

CompanyDevicesShare
Plasdent Corporation2547%
Premium Plus International Limited1223%
Jmu Dental, Inc48%
Pulpdent Corporation48%
Parkell, Inc.24%
Peter Brasseler Holdings, Llc12%
A. Titan Instruments, Inc.12%
Salvin Dental Specialties, Llc12%
Cosmedent, Inc.12%
Osung Mnd Co., Ltd.12%
Mc Bio Srl12%

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

Brand names on the register (sample)

Brasseler USAPremium PlusFLOWBOWLSPECTRUM FLOWBOWLPlasdentACUWELLA. Titan InstrumentsSalvin Stainless Steel Weighted Graft Material DJMUResinKeeperMini-BowlsC&B MetaBond®Parkell®OSUNG MNDBone Graft Container

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, Accessories26
JDZMixer, Cement, For Clinical Use19
NDPAccessories, Implant, Dental, Endosseous3
KXRApplicator, Resin3
KLEAgent, Tooth Bonding, Resin2
GAFSPATULA, SURGICAL, GENERAL & PLASTIC SURGERY1

GMDN & GCC registration

  • GMDN code 63877 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 8% · 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, reusable products are registered in the US?

53 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, reusable", from 11 companies. The largest labeler is Plasdent Corporation with 47% of records.

Which FDA product codes apply?

NRD (Unit, Operative Dental, Accessories), JDZ (Mixer, Cement, For Clinical Use), NDP (Accessories, Implant, Dental, Endosseous), KXR (Applicator, Resin)

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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