Consulting Wallah › Device Explorer › Dental › Margin finishing dental file/rasp, reusable
Device Explorer · FDA GUDID · GMDN 31863

Margin finishing dental file/rasp, reusable

A hand-held manual dental instrument that has various forms of fine ridged cutting surfaces at its working end(s) designed to smooth and shape a tooth, an approximate bone (e.g., alveolar) and/or a dental restoration (e.g., filling). It is typically a one-piec

US‑registered devices688in commercial distribution
Companies21labelers on GUDID
Single‑use5%of device records
Sterile0%labelled sterile
Prescription11%Rx‑only share
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Share of device records

Nordent Manufacturing Inc43463%
Hu-Friedy Mfg. Co., Llc599%
Gc Orthodontics America Inc.365%
Zoll-Dental335%
Power Dental U.S.A. Inc.254%
A. Titan Instruments, Inc.193%
Darby Dental Supply, Llc122%
J & J Instruments Inc101%

Top labelers

CompanyDevicesShare
Nordent Manufacturing Inc43463%
Hu-Friedy Mfg. Co., Llc599%
Gc Orthodontics America Inc.365%
Zoll-Dental335%
Power Dental U.S.A. Inc.254%
A. Titan Instruments, Inc.193%
Darby Dental Supply, Llc122%
J & J Instruments Inc101%
Premier Dental Products Company101%
Henry Schein, Inc.101%
Lm-Dental81%
Peter Brasseler Holdings, Llc71%

Company = labeler of record on GUDID. 21 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Endo Rotary fileLMDentalKOHDENTDentaSonicDarby Dental Supply, LLCPower Dental USAPower Dental U.S.A., Inc.Brasseler USATweakz for AlignersNACERTAIN®Ceri-Saw™A. Titan 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
EKDInstrument, Cutting, Operative445
EJZKNIFE, MARGIN FINISHING, OPERATIVE90
EMIFILE, BONE, SURGICAL70
DZNInstruments, Dental Hand36
EIYINSTRUMENT, FILLING, PLASTIC, DENTAL25
EMRFILE, PERIODONTIC11

GMDN & GCC registration

  • GMDN code 31863 · non‑implantable
  • Single‑use 5% · sterile 0% · Rx‑only 11% · 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

Length (Inch) · 10

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

No closely related category with 50+ devices.

How many margin finishing dental file/rasp, reusable products are registered in the US?

688 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Margin finishing dental file/rasp, reusable", from 21 companies. The largest labeler is Nordent Manufacturing Inc with 63% of records.

Which FDA product codes apply?

EKD (Instrument, Cutting, Operative), EJZ (KNIFE, MARGIN FINISHING, OPERATIVE), EMI (FILE, BONE, SURGICAL), DZN (Instruments, Dental Hand)

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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