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Device Explorer · FDA GUDID · GMDN 38777

Endodontic paper point

A non-medicated absorbent point used in endodontic procedures that has been sterilized once in a manner approved by the manufacturer. This is a single-use device.

US‑registered devices4,721in commercial distribution
Companies32labelers on GUDID
Single‑use100%of device records
Sterile80%labelled sterile
Prescription59%Rx‑only share
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Share of device records

Diadent Group International1,73637%
Meta Biomed Co., Ltd.67914%
Maillefer Instruments Holding Sàrl2465%
Henry Schein, Inc.2345%
Sure Dent Corporation1764%
Tulsa Dental Products Llc1704%
Us Endodontics, Llc1694%
Shanghai Xing Yu Medical Equipment Co.,Ltd.1684%

Top labelers

CompanyDevicesShare
Diadent Group International1,73637%
Meta Biomed Co., Ltd.67914%
Maillefer Instruments Holding Sàrl2465%
Henry Schein, Inc.2345%
Sure Dent Corporation1764%
Tulsa Dental Products Llc1704%
Us Endodontics, Llc1694%
Shanghai Xing Yu Medical Equipment Co.,Ltd.1684%
Safco Dental Supply Co.1573%
Darby Dental Supply, Llc1062%
Coltène/Whaledent Gmbh + Co. Kg1052%
The Atlanta Dental Supply Company962%

Company = labeler of record on GUDID. 32 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

EndoEssentials™ Absorbent Paper Points 200 - XCEndoEssentials™ Absorbent Paper Points 200 - CEndoEssentials™ Absorbent Paper Points 200 - MEndoEssentials™ Absorbent Paper Points 200 - FEndoEssentials™ Absorbent Paper Points 200 - XFEndoEssentials™ Absorbent Paper Points 100 - F3 EndoEssentials™ Absorbent Paper Points 100 - F2 EndoEssentials™ Absorbent Paper Points 100 - F1 EndoEssentials™ Absorbent Paper Points 200 - ISOEndoEssentials™ Absorbent Paper Points 200 - ISOEndoEssentials™ Absorbent Paper Points 100 - #45EndoEssentials™ Absorbent Paper Points 100 - #40EndoEssentials™ Absorbent Paper Points 100 - #35EndoEssentials™ Absorbent Paper Points 100 - #30EndoEssentials™ Absorbent Paper Points 100 - #25EndoEssentials™ Absorbent Paper Points 100 - #20

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

FDA product codes

CodeNameDevices
EKNPoint, Paper, Endodontic3,198
EKNPOINT, PAPER, ENDODONTIC1,556
EKMGUTTA-PERCHA18
EKMGutta-Percha1

GMDN & GCC registration

  • GMDN code 38777 · non‑implantable
  • Single‑use 100% · sterile 80% · Rx‑only 59% · 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 paper point products are registered in the US?

4,721 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Endodontic paper point", from 32 companies. The largest labeler is Diadent Group International with 37% of records.

Which FDA product codes apply?

EKN (Point, Paper, Endodontic), EKN (POINT, PAPER, ENDODONTIC), EKM (GUTTA-PERCHA), EKM (Gutta-Percha)

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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