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Device Explorer · FDA GUDID · GMDN 45081

Synthetic gutta-percha

A dental material made from a polymer-based, synthetic gutta-percha containing fillers and radiopacifiers in a soft resin matrix, intended to fill the root canal of a tooth. This material has the ability to resist leakage significantly better than natural gutt

US‑registered devices2,346in commercial distribution
Companies20labelers on GUDID
Single‑use100%of device records
Sterile4%labelled sterile
Prescription60%Rx‑only share
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Share of device records

Meta Biomed Co., Ltd.52722%
Henry Schein, Inc.28712%
Tulsa Dental Products Llc28512%
Sure Dent Corporation25811%
Maillefer Instruments Holding Sàrl2149%
Us Endodontics, Llc1838%
Peter Brasseler Holdings, Llc1034%
Safco Dental Supply Co.984%

Top labelers

CompanyDevicesShare
Meta Biomed Co., Ltd.52722%
Henry Schein, Inc.28712%
Tulsa Dental Products Llc28512%
Sure Dent Corporation25811%
Maillefer Instruments Holding Sàrl2149%
Us Endodontics, Llc1838%
Peter Brasseler Holdings, Llc1034%
Safco Dental Supply Co.984%
Darby Dental Supply, Llc884%
3D Dental Designs And Development, Llc823%
The Atlanta Dental Supply Company683%
Roydent Dental Products Inc442%

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

Brand names on the register (sample)

EndoEssentials™ Gutta Percha Points F3 - EE PT SEndoEssentials™ Gutta Percha Points F2 - EE PT SEndoEssentials™ Gutta Percha Points F1 - EE PT SEndoEssentials™ Gutta Percha Points XL - Non-StaEndoEssentials™ Gutta Percha Points L - Non-StanEndoEssentials™ Gutta Percha Points ML - Non-StaEndoEssentials™ Gutta Percha Points M - Non-StanEndoEssentials™ Gutta Percha Points FM - Non-StaEndoEssentials™ Gutta Percha Points F - Non-StanEndoEssentials™ Gutta Percha Points MF - Non-StaEndoEssentials™ Gutta Percha Points FF - Non-StaEndoEssentials™ Gutta Percha Points Size 20-45 AEndoEssentials™ Gutta Percha Points Size 20-45 AEndoEssentials™ Gutta Percha Points ISO#45-80 AsEndoEssentials™ Gutta Percha Points ISO#15-40 AsEndoEssentials™ Gutta Percha Points Size 45 .06

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

FDA product codes

CodeNameDevices
EKMGUTTA-PERCHA1,542
EKMGutta-Percha933
EKNPOINT, PAPER, ENDODONTIC12
EMACement, Dental1

GMDN & GCC registration

  • GMDN code 45081 · non‑implantable
  • Single‑use 100% · sterile 4% · Rx‑only 60% · 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 synthetic gutta-percha products are registered in the US?

2,346 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Synthetic gutta-percha", from 20 companies. The largest labeler is Meta Biomed Co., Ltd. with 22% of records.

Which FDA product codes apply?

EKM (GUTTA-PERCHA), EKM (Gutta-Percha), EKN (POINT, PAPER, ENDODONTIC), 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.

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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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