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Device Explorer · FDA GUDID · GMDN 31868

Dental laboratory mandrel

A round shaft of substantial dimensions designed to be used in the dental laboratory to hold (locked into place) a rotating device, e.g., a grinding or polishing wheel, abrasive disk, circular saw, or a disk, stone or cup used for grinding or polishing; connec

US‑registered devices72in commercial distribution
Companies8labelers on GUDID
Single‑use3%of device records
Sterile0%labelled sterile
Prescription28%Rx‑only share
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Share of device records

Edenta Etablissement4056%
Integra Lifesciences Production Corporation1217%
Plasdent Corporation68%
Nti - Kahla Gmbh Rotary Dental Instruments57%
Dentaurum Gmbh & Co.Kg46%
Shofu Dental Corporation23%
Preat Corporation23%
Jordco Inc11%

Top labelers

CompanyDevicesShare
Edenta Etablissement4056%
Integra Lifesciences Production Corporation1217%
Plasdent Corporation68%
Nti - Kahla Gmbh Rotary Dental Instruments57%
Dentaurum Gmbh & Co.Kg46%
Shofu Dental Corporation23%
Preat Corporation23%
Jordco Inc11%

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

Brand names on the register (sample)

EDENTANTIHP MANDRELSUPER-SNAPPure BuffPlasdentPreatO-RingIntegra® Miltex®N.A.

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

FDA product codes

CodeNameDevices
EJQWHEEL, POLISHING AGENT49
DZADRILL, DENTAL, INTRAORAL25
EHJDISK, ABRASIVE12
NRDUnit, Operative Dental, Accessories6
EJLBUR, DENTAL2
NDPAccessories, Implant, Dental, Endosseous2

GMDN & GCC registration

  • GMDN code 31868 · non‑implantable
  • Single‑use 3% · sterile 0% · Rx‑only 28% · OTC 1%
  • 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 laboratory mandrel products are registered in the US?

72 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental laboratory mandrel", from 8 companies. The largest labeler is Edenta Etablissement with 56% of records.

Which FDA product codes apply?

EJQ (WHEEL, POLISHING AGENT), DZA (DRILL, DENTAL, INTRAORAL), EHJ (DISK, ABRASIVE), NRD (Unit, Operative Dental, Accessories)

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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