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Device Explorer · FDA GUDID · GMDN 63550

Rotary/reciprocating endodontic file/rasp, single-use

A dental endpiece designed to be attached to a rotary or reciprocating dental power tool handpiece to debride and enlarge the root canal and smooth its walls by cutting or abrasion. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] a

US‑registered devices3,921in commercial distribution
Companies31labelers on GUDID
Single‑use97%of device records
Sterile43%labelled sterile
Prescription63%Rx‑only share
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Share of device records

Us Endodontics, Llc76720%
Ss White Burs, Inc.49913%
Fkg Dentaire Sàrl2907%
Peter Brasseler Holdings, Llc2777%
Tulsa Dental Products Llc2276%
Micro Mega1935%
Roydent Dental Products Inc1775%
Easy Equipamentos Odontologicos Ltda.1574%

Top labelers

CompanyDevicesShare
Us Endodontics, Llc76720%
Ss White Burs, Inc.49913%
Fkg Dentaire Sàrl2907%
Peter Brasseler Holdings, Llc2777%
Tulsa Dental Products Llc2276%
Micro Mega1935%
Roydent Dental Products Inc1775%
Easy Equipamentos Odontologicos Ltda.1574%
Sonendo, Inc.1464%
Scott'S Dental Supply L.L.C.1434%
Nusmile, Ltd.1343%
Top Quality Manufacturing, Inc.1113%

Company = labeler of record on GUDID. 31 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ISRIEC-RootSmartVaryFlex Reciprocating, VFRF 50, 31mmVaryFlex Reciprocating, VFRF 50, 25mmVaryFlex Reciprocating, VFRF 50, 21mmVaryFlex Flow, VFF 31mm Size 50/06VaryFlex Flow, VFF 31mm Size 45/06VaryFlex Flow, VFF 25mm Size 50/06VaryFlex Flow, VFF 25mm Size 45/06VaryFlex Flow, VFF 21mm Size 50/06VaryFlex Flow, VFF 21mm Size 45/06VaryFlex Flow, VFF 31mm Size 50/04VaryFlex Flow, VFF 31mm Size 45/04VaryFlex Flow, VFF 25mm Size 50/04VaryFlex Flow, VFF 25mm Size 45/04

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

FDA product codes

CodeNameDevices
EKSFILE, PULP CANAL, ENDODONTIC2,393
EKSFile, Pulp Canal, Endodontic1,498
EKQPREPARER, ROOT CANAL ENDODONTIC111
DZADRILL, DENTAL, INTRAORAL54
NDPAccessories, Implant, Dental, Endosseous50
EKPREAMER, PULP CANAL, ENDODONTIC34

GMDN & GCC registration

  • GMDN code 63550 · non‑implantable
  • Single‑use 97% · sterile 43% · Rx‑only 63% · 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 rotary/reciprocating endodontic file/rasp, single-use products are registered in the US?

3,921 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Rotary/reciprocating endodontic file/rasp, single-use", from 31 companies. The largest labeler is Us Endodontics, Llc with 20% of records.

Which FDA product codes apply?

EKS (FILE, PULP CANAL, ENDODONTIC), EKS (File, Pulp Canal, Endodontic), EKQ (PREPARER, ROOT CANAL ENDODONTIC), DZA (DRILL, DENTAL, INTRAORAL)

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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