Consulting Wallah › Device Explorer › Other devices › Endodontic stopper
Device Explorer · FDA GUDID · GMDN 45123

Endodontic stopper

A device that is used as a measuring reference point on an endodontic instrument used in a root canal procedure. It is typically designed as a flat ring made of an elastic material (e.g., silicone) that is placed at a predetermined distance from the distal end

US‑registered devices99in commercial distribution
Companies6labelers on GUDID
Single‑use38%of device records
Sterile18%labelled sterile
Prescription82%Rx‑only share
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Share of device records

Dentis Co. ,Ltd6465%
Polydentia Sa1717%
Henry Schein, Inc.1212%
Essential Dental Systems, Inc.44%
Edenta Etablissement11%
Benco Dental Supply Co.11%

Top labelers

CompanyDevicesShare
Dentis Co. ,Ltd6465%
Polydentia Sa1717%
Henry Schein, Inc.1212%
Essential Dental Systems, Inc.44%
Edenta Etablissement11%
Benco Dental Supply Co.11%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

EDENTAendo-stopstop cardFlexi-PostFlexi-FlangeFlexi-OverdentureBENCOHenry ScheinStopperLateral StopperCrestal StopperDrilling Guide Wheel"Drilling Guide Wheel"""Drilling Guide WheelStopper SupportDrill Holder

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

FDA product codes

CodeNameDevices
NDPAccessories, Implant, Dental, Endosseous64
EKSFILE, PULP CANAL, ENDODONTIC41
DZNInstruments, Dental Hand17
EILGAUGE, DEPTH, INSTRUMENT, DENTAL6
DZADRILL, DENTAL, INTRAORAL1
EIYINSTRUMENT, FILLING, PLASTIC, DENTAL1

GMDN & GCC registration

  • GMDN code 45123 · non‑implantable
  • Single‑use 38% · sterile 18% · Rx‑only 82% · 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 endodontic stopper products are registered in the US?

99 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Endodontic stopper", from 6 companies. The largest labeler is Dentis Co. ,Ltd with 65% of records.

Which FDA product codes apply?

NDP (Accessories, Implant, Dental, Endosseous), EKS (FILE, PULP CANAL, ENDODONTIC), DZN (Instruments, Dental Hand), EIL (GAUGE, DEPTH, INSTRUMENT, 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.

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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