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Device Explorer · FDA GUDID · GMDN 35868

Dental restoration retention pin

A device intended to be placed permanently in the tooth to provide retention and/or stabilization for a dental restoration (e.g., a filling or a crown). It is typically made of stainless steel or titanium (Ti) and comes in a variety of sizes (e.g., 1.0 mm to 3

US‑registered devices109in commercial distribution
Companies8labelers on GUDID
Single‑use68%of device records
Sterile0%labelled sterile
Prescription66%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Coltene/Whaledent Inc6156%
Edenta Etablissement2826%
Fairfax Medical Products Limited87%
Micerium Spa66%
Almore International Inc22%
Gc America Inc.22%
Ace Surgical Supply Co., Inc.11%
Henry Schein, Inc.11%

Top labelers

CompanyDevicesShare
Coltene/Whaledent Inc6156%
Edenta Etablissement2826%
Fairfax Medical Products Limited87%
Micerium Spa66%
Almore International Inc22%
Gc America Inc.22%
Ace Surgical Supply Co., Inc.11%
Henry Schein, Inc.11%

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

Brand names on the register (sample)

Ena PostStabilokEDENTAMarkley Threaded Wire .064Markley Threaded Wire .018TMSMaxBondentMINIMInfinity External Hex Implant SystemHenry ScheineverStick®

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

FDA product codes

CodeNameDevices
EBLPin, Retentive And Splinting, And Accessory Instruments68
EBLPIN, RETENTIVE AND SPLINTING, AND ACCESSORY INSTRUMENTS28
ELRPost, Root Canal5
DZNInstruments, Dental Hand3
EBIRESIN, DENTURE, RELINING, REPAIRING, REBASING2
EJLBur, Dental1

GMDN & GCC registration

  • GMDN code 35868 · implantable
  • Single‑use 68% · sterile 0% · Rx‑only 66% · 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

Outer Diameter (Millimeter) · 14Length (Millimeter) · 7

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

How many dental restoration retention pin products are registered in the US?

109 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental restoration retention pin", from 8 companies. The largest labeler is Coltene/Whaledent Inc with 56% of records.

Which FDA product codes apply?

EBL (Pin, Retentive And Splinting, And Accessory Instruments), EBL (PIN, RETENTIVE AND SPLINTING, AND ACCESSORY INSTRUMENTS), ELR (Post, Root Canal), DZN (Instruments, Dental Hand)

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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