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Device Explorer · FDA GUDID · GMDN 31872

Natural gutta-percha

A dental material made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. This material is softened by heat and inserted into the root canal, where it hardens as it cools. After application, this device cannot be reused.

US‑registered devices2,824in commercial distribution
Companies20labelers on GUDID
Single‑use100%of device records
Sterile1%labelled sterile
Prescription78%Rx‑only share
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Share of device records

Diadent Group International2,08374%
Shanghai Xing Yu Medical Equipment Co.,Ltd.27210%
Ss White Burs, Inc.803%
Top Quality Manufacturing, Inc.512%
Scott'S Dental Supply L.L.C.482%
Benco Dental Supply Co.421%
Produits Dentaires S.A.401%
Peter Brasseler Holdings, Llc391%

Top labelers

CompanyDevicesShare
Diadent Group International2,08374%
Shanghai Xing Yu Medical Equipment Co.,Ltd.27210%
Ss White Burs, Inc.803%
Top Quality Manufacturing, Inc.512%
Scott'S Dental Supply L.L.C.482%
Benco Dental Supply Co.421%
Produits Dentaires S.A.401%
Peter Brasseler Holdings, Llc391%
Nusmile, Ltd.351%
Patterson Dental Supply, Inc.331%
Tulsa Dental Products Llc321%
Henry Schein, Inc.231%

Company = labeler of record on GUDID. 20 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

JAS Gutta-Percha PelletsAVALON BIOMEDZarcKPEXIMIA7Gutta Percha PointsDC TaperJMUBrasseler USAEndoREZ PointsObtura SpartanSCOTT'S GUTTA PERCHA P-TAPER 100/bx CC # F3SCOTT'S GUTTA PERCHA P-TAPER 100/bx CC # F2SCOTT'S GUTTA PERCHA P-TAPER 100/bx CC # F1SCOTT'S GUTTA PERCHA .06 TAPER 100/bx CC # 15-40SCOTT'S GUTTA PERCHA .06 TAPER 100/bx CC # 50

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

FDA product codes

CodeNameDevices
EKMGutta-Percha2,491
EKMGUTTA-PERCHA337
EKNPoint, Paper, Endodontic9

GMDN & GCC registration

  • GMDN code 31872 · non‑implantable
  • Single‑use 100% · sterile 1% · Rx‑only 78% · 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 natural gutta-percha products are registered in the US?

2,824 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Natural gutta-percha", from 20 companies. The largest labeler is Diadent Group International with 74% of records.

Which FDA product codes apply?

EKM (Gutta-Percha), EKM (GUTTA-PERCHA), EKN (Point, Paper, 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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