Consulting Wallah › Device Explorer › Other devices › Rotary/reciprocating endodontic file/rasp, reusabl
Device Explorer · FDA GUDID · GMDN 40529

Rotary/reciprocating endodontic file/rasp, reusable

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 devices2,902in commercial distribution
Companies26labelers on GUDID
Single‑use44%of device records
Sterile22%labelled sterile
Prescription32%Rx‑only share
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Share of device records

Tulsa Dental Products Llc67023%
Guilin Kevin Peter Technology Co., Ltd.36413%
Mani, Inc.29710%
Endo Direct Llc2268%
Coltene/Whaledent Inc2198%
Peter Brasseler Holdings, Llc2097%
Clinician'S Choice Dental Products, Inc.1365%
The Atlanta Dental Supply Company1284%

Top labelers

CompanyDevicesShare
Tulsa Dental Products Llc67023%
Guilin Kevin Peter Technology Co., Ltd.36413%
Mani, Inc.29710%
Endo Direct Llc2268%
Coltene/Whaledent Inc2198%
Peter Brasseler Holdings, Llc2097%
Clinician'S Choice Dental Products, Inc.1365%
The Atlanta Dental Supply Company1284%
Changzhou Sifary Medical Technology Co., Ltd.1013%
United Dental Changzhou993%
Meta Biomed Co., Ltd.722%
Coltène/Whaledent Gmbh + Co. Kg632%

Company = labeler of record on GUDID. 26 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

X-Plorer™ Canal Navigation Files 15/01, 20/01, 2X-Plorer™ Canal Navigation Files 15/.01 (21mm)X-Plorer™ Canal Navigation Files 15/.01 (25mm)X-Factor™ Minimally Invasive NiTi Files CM 35/.0X-Factor™ Minimally Invasive NiTi Files CM 30/.0X-Factor™ Minimally Invasive NiTi Files CM 25/.0X-Factor™ Minimally Invasive NiTi Files CM 20/.0Typhoon™ Infinite Flex NiTi Files Crown Down PacTyphoon™ Infinite Flex NiTi Files Assorted SizesTyphoon™ Infinite Flex NiTi Files 35/.06 (31mm)Typhoon™ Infinite Flex NiTi Files 30/.06 (31mm)Typhoon™ Infinite Flex NiTi Files 25/.06 (31mm)Typhoon™ Infinite Flex NiTi Files 20/.06 (31mm)Typhoon™ Infinite Flex NiTi Files 50/.04 (31mm)Typhoon™ Infinite Flex NiTi Files 45/.04 (31mm)Typhoon™ Infinite Flex NiTi Files 40/.04 (31mm)

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, ENDODONTIC1,791
EKSFile, Pulp Canal, Endodontic858
DZADrill, Dental, Intraoral153
EKPREAMER, PULP CANAL, ENDODONTIC80
DZADRILL, DENTAL, INTRAORAL66
EJLBur, Dental22

GMDN & GCC registration

  • GMDN code 40529 · non‑implantable
  • Single‑use 44% · sterile 22% · Rx‑only 32% · 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 (Millimeter) · 149

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

How many rotary/reciprocating endodontic file/rasp, reusable products are registered in the US?

2,902 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, reusable", from 26 companies. The largest labeler is Tulsa Dental Products Llc with 23% of records.

Which FDA product codes apply?

EKS (FILE, PULP CANAL, ENDODONTIC), EKS (File, Pulp Canal, Endodontic), DZA (Drill, Dental, Intraoral), EKP (REAMER, PULP CANAL, ENDODONTIC)

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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