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Device Explorer · FDA GUDID · GMDN 64815

Endodontic instrument-holding insert, single-use

A device intended to be fitted into an endodontic instrument holder housing and used chairside during a dental endodontic procedure to hold and temporarily store sharp endodontic instruments (e.g., files/rasps). It is in the form of a spongy foam insert into w

US‑registered devices107in commercial distribution
Companies8labelers on GUDID
Single‑use21%of device records
Sterile0%labelled sterile
Prescription10%Rx‑only share
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Share of device records

Safco Dental Supply Co.8277%
Jordco Inc66%
Zirc Dental Products, Inc.66%
Plasdent Corporation44%
Henry Schein, Inc.44%
3D Dental Designs And Development, Llc22%
The Atlanta Dental Supply Company22%
Peter Brasseler Holdings, Llc11%

Top labelers

CompanyDevicesShare
Safco Dental Supply Co.8277%
Jordco Inc66%
Zirc Dental Products, Inc.66%
Plasdent Corporation44%
Henry Schein, Inc.44%
3D Dental Designs And Development, Llc22%
The Atlanta Dental Supply Company22%
Peter Brasseler Holdings, Llc11%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Brasseler USAEnodringEndoringPlasdentSafco Maxim K Files and HedstromPatterson Dental - Steri-Endo Guard, Endo AssistEndo Assist Stand - Replacement Foam - 144 countEndo Assist Stand - Replacement Foam - 48 countSteri-Endo Guard, Endo Assist - Replacement FoamSteri-Endo Guard, Endo Assist - Replacement Foam3D DentalHenry ScheinFoam Insert (Accessory) (Single-Use) 48-packAdvance Dental Products

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, ENDODONTIC82
EILGauge, Depth, Instrument, Dental6
FSMTray, Surgical, Instrument6
NABGauze / Sponge,Nonresorbable For External Use4
FTYTAPE, MEASURING, RULERS AND CALIPERS4
NRDUnit, Operative Dental, Accessories2

GMDN & GCC registration

  • GMDN code 64815 · non‑implantable
  • Single‑use 21% · sterile 0% · Rx‑only 10% · OTC 6%
  • 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) · 6Width (Millimeter) · 6Height (Millimeter) · 6

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

How many endodontic instrument-holding insert, single-use products are registered in the US?

107 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Endodontic instrument-holding insert, single-use", from 8 companies. The largest labeler is Safco Dental Supply Co. with 77% of records.

Which FDA product codes apply?

EKS (FILE, PULP CANAL, ENDODONTIC), EIL (Gauge, Depth, Instrument, Dental), FSM (Tray, Surgical, Instrument), NAB (Gauze / Sponge,Nonresorbable For External Use)

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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