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Device Explorer · FDA GUDID · GMDN 64078

Manual dental burnisher, reusable

A hand-held manual dental device with a smooth or ribbed working head intended to be used to create thin margins between a dental restoration and the enamel at the cavo-surface angle, and/or to polish the surface of metallic restorations by rubbing. Its termin

US‑registered devices749in commercial distribution
Companies29labelers on GUDID
Single‑use5%of device records
Sterile3%labelled sterile
Prescription11%Rx‑only share
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Share of device records

Nordent Manufacturing Inc17323%
Lm-Dental15921%
Hu-Friedy Mfg. Co., Llc12316%
Zoll-Dental365%
Karl Schumacher Dental, Llc324%
American Eagle Instruments, Inc.294%
Bmt Medizintechnik Gmbh274%
J & J Instruments Inc223%

Top labelers

CompanyDevicesShare
Nordent Manufacturing Inc17323%
Lm-Dental15921%
Hu-Friedy Mfg. Co., Llc12316%
Zoll-Dental365%
Karl Schumacher Dental, Llc324%
American Eagle Instruments, Inc.294%
Bmt Medizintechnik Gmbh274%
J & J Instruments Inc223%
A. Titan Instruments, Inc.213%
Pomee Corporation213%
Darby Dental Supply, Llc172%
Pdt, Inc.142%

Company = labeler of record on GUDID. 29 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

LMDentalBMT Medizintechnik GmbHPRODONT-HOLLIGERDarby Dental Supply, LLCPower Dental U.S.A., Inc.Power Dental USABrasseler USAIntrace USAKarl SchumacherA. Titan InstrumentsAmerican Eagle Instruments, Inc.American Eagle InstrumentsHealth-Tec/DHP Hand InstrumentsZOLL-DENTALNordent Manufacturing, Inc.NORDENT MANUFACTURING INC

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

FDA product codes

CodeNameDevices
EKJBURNISHER, OPERATIVE294
EKJBurnisher, Operative272
DZNInstruments, Dental Hand195
EIYINSTRUMENT, FILLING, PLASTIC, DENTAL42
DZNINSTRUMENTS, DENTAL HAND22
EKGCONDENSER, AMALGAM AND FOIL, OPERATIVE17

GMDN & GCC registration

  • GMDN code 64078 · non‑implantable
  • Single‑use 5% · sterile 3% · Rx‑only 11% · 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

Length (Inch) · 31Outer Diameter (Millimeter) · 8

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

How many manual dental burnisher, reusable products are registered in the US?

749 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Manual dental burnisher, reusable", from 29 companies. The largest labeler is Nordent Manufacturing Inc with 23% of records.

Which FDA product codes apply?

EKJ (BURNISHER, OPERATIVE), EKJ (Burnisher, Operative), DZN (Instruments, Dental Hand), EIY (INSTRUMENT, FILLING, PLASTIC, DENTAL)

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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