Consulting Wallah › Device Explorer › Dental › Hand-held dental retractor
Device Explorer · FDA GUDID · GMDN 13380

Hand-held dental retractor

A hand-held, non-self-retaining dental instrument intended to be used to manually displace soft tissues of the oral cavity to improve their visualization and access, and to afford them protection during oral surgical procedures. It is typically a metallic devi

US‑registered devices1,325in commercial distribution
Companies80labelers on GUDID
Single‑use5%of device records
Sterile1%labelled sterile
Prescription71%Rx‑only share
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Share of device records

Avalign Technologies, Inc.16512%
Bmt Medizintechnik Gmbh1149%
Kls-Martin L.P.1058%
Ace Surgical Supply Co., Inc.856%
Zoll-Dental826%
Kohler Medizintechnik Gmbh715%
Devemed Gmbh665%
Storz Am Mark Gmbh504%

Top labelers

CompanyDevicesShare
Avalign Technologies, Inc.16512%
Bmt Medizintechnik Gmbh1149%
Kls-Martin L.P.1058%
Ace Surgical Supply Co., Inc.856%
Zoll-Dental826%
Kohler Medizintechnik Gmbh715%
Devemed Gmbh665%
Storz Am Mark Gmbh504%
Teleflex Incorporated413%
Zyris, Inc.363%
Aesculap Ag353%
Densol International (Private) Limited282%

Company = labeler of record on GUDID. 80 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NAPRO-OPTIONSLip RetractorCheek retractorOral retractorInion® Universal instrumentsLMDentalN/AInstrapacDENTECHCEKA & PRECI-LINE ATTACHMENTSBMT Medizintechnik GmbHKOHLERKOHDENTSCHWERTReicodent

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

FDA product codes

CodeNameDevices
EIGRETRACTOR, ALL TYPES652
EIGRetractor, All Types272
EIFACCESSORIES, RETRACTOR, DENTAL65
EIFAccessories, Retractor, Dental64
GADRETRACTOR47
KALRETRACTOR, ENT39

GMDN & GCC registration

  • GMDN code 13380 · non‑implantable
  • Single‑use 5% · sterile 1% · Rx‑only 71% · OTC 4%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Inch) · 79Width (Millimeter) · 16Length (Millimeter) · 11Length (Centimeter) · 4Width (Centimeter) · 1

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

How many hand-held dental retractor products are registered in the US?

1,325 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Hand-held dental retractor", from 80 companies. The largest labeler is Avalign Technologies, Inc. with 12% of records.

Which FDA product codes apply?

EIG (RETRACTOR, ALL TYPES), EIG (Retractor, All Types), EIF (ACCESSORIES, RETRACTOR, DENTAL), EIF (Accessories, Retractor, 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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