Consulting Wallah › Device Explorer › Other devices › Endodontic filling/sealing material
Device Explorer · FDA GUDID · GMDN 36095

Endodontic filling/sealing material

A prefabricated, solid dental substance used in endodontics to fill or permanently obturate the root canal of a tooth. The substance may set without assistance of moisture, and is typically intended for orthograde use (i.e., a root filling placed from the coro

US‑registered devices146in commercial distribution
Companies29labelers on GUDID
Single‑use34%of device records
Sterile4%labelled sterile
Prescription80%Rx‑only share
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Share of device records

Diadent Group International2215%
Angelus Industria De Produtos Odontologicos S A1712%
Coltène/Whaledent Gmbh + Co. Kg1510%
Dentsply De Trey Gmbh96%
Pulpdent Corporation85%
Dentonics Inc75%
Vericom Co., Ltd.75%
Edge Endo Llc64%

Top labelers

CompanyDevicesShare
Diadent Group International2215%
Angelus Industria De Produtos Odontologicos S A1712%
Coltène/Whaledent Gmbh + Co. Kg1510%
Dentsply De Trey Gmbh96%
Pulpdent Corporation85%
Dentonics Inc75%
Vericom Co., Ltd.75%
Edge Endo Llc64%
Biomta64%
Septodont Sas Specialites Septodont53%
Benco Dental Supply Co.53%
Henry Schein, Inc.53%

Company = labeler of record on GUDID. 29 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ROOT CANAL CEMENT 15GM/7.5MLOxford MTA HandmixOxford Root FILL SystemDentalisOBTURYSBioRoot RCS Liquid Refill KitACROSEAL AUTOMIXBIOROOT RCSACROSEAL TUBEENDOMET KITROEKO GuttaFlow®2HYGENIC® GuttaFlow®2ROEKO RoekoSeal Single DoseROEKO RoekoSeal AutomixSimpliSealEndoREZ

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

FDA product codes

CodeNameDevices
KIFResin, Root Canal Filling111
KIFRESIN, ROOT CANAL FILLING19
EKMGutta-Percha11
EMACement, Dental7
EJKLiner, Cavity, Calcium Hydroxide2
EMACEMENT, DENTAL1

GMDN & GCC registration

  • GMDN code 36095 · non‑implantable
  • Single‑use 34% · sterile 4% · Rx‑only 80% · 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

Weight (Gram) · 24Total Volume (Milliliter) · 6Total Volume (Fluid Ounce) · 4Length (Centimeter) · 1

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

How many endodontic filling/sealing material products are registered in the US?

146 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Endodontic filling/sealing material", from 29 companies. The largest labeler is Diadent Group International with 15% of records.

Which FDA product codes apply?

KIF (Resin, Root Canal Filling), KIF (RESIN, ROOT CANAL FILLING), EKM (Gutta-Percha), EMA (Cement, 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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