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Device Explorer · FDA GUDID · GMDN 63622

Endodontic obturation material distribution endpiece, single-use

A dental endpiece designed to be attached to a dental power tool handpiece to distribute root canal sealer/cement/paste evenly throughout the root canal system typically by applying the material in a lateral direction. It is a thin metal rod with a spiral (e.g

US‑registered devices88in commercial distribution
Companies4labelers on GUDID
Single‑use86%of device records
Sterile6%labelled sterile
Prescription62%Rx‑only share
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Share of device records

Darby Dental Supply, Llc3742%
3D Dental Designs And Development, Llc3338%
Peter Brasseler Holdings, Llc1618%
Us Endodontics, Llc22%

Top labelers

CompanyDevicesShare
Darby Dental Supply, Llc3742%
3D Dental Designs And Development, Llc3338%
Peter Brasseler Holdings, Llc1618%
Us Endodontics, Llc22%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Darby Dental Supply, LLCBrasseler USAEdgeFlow™3D Dental Endo3D Endo

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

FDA product codes

CodeNameDevices
EKKSPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC60
EIYInstrument, Filling, Plastic, Dental24
EKRPLUGGER, ROOT CANAL, ENDODONTIC9
EIYINSTRUMENT, FILLING, PLASTIC, DENTAL8
EICSYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING5
EKSFILE, PULP CANAL, ENDODONTIC3

GMDN & GCC registration

  • GMDN code 63622 · non‑implantable
  • Single‑use 86% · sterile 6% · Rx‑only 62% · 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 obturation material distribution endpiece, single-use products are registered in the US?

88 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Endodontic obturation material distribution endpiece, single-use", from 4 companies. The largest labeler is Darby Dental Supply, Llc with 42% of records.

Which FDA product codes apply?

EKK (SPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC), EIY (Instrument, Filling, Plastic, Dental), EKR (PLUGGER, ROOT CANAL, ENDODONTIC), 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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