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Device Explorer · FDA GUDID · GMDN 31815

Dental cotton roll

A non-sterile designed as an absorbent, non-sterile mass of cotton or man-made fibres formed as a small, short, hard-packed cylinder (a roll) that is used as a saliva absorber and intended to absorb moisture from the oral cavity during dental procedures. It ma

US‑registered devices52in commercial distribution
Companies21labelers on GUDID
Single‑use96%of device records
Sterile4%labelled sterile
Prescription6%Rx‑only share
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Share of device records

Polydentia Sa917%
Euronda Spa815%
Jmu Dental, Inc48%
Avaline Medical Nj Limited Liability Company48%
Pascal Company, Inc.48%
Plasdent Corporation36%
Purelife, Llc36%
American Orthodontics Corporation36%

Top labelers

CompanyDevicesShare
Polydentia Sa917%
Euronda Spa815%
Jmu Dental, Inc48%
Avaline Medical Nj Limited Liability Company48%
Pascal Company, Inc.48%
Plasdent Corporation36%
Purelife, Llc36%
American Orthodontics Corporation36%
Ascend Eagle Incorporated24%
Darby Dental Supply, Llc12%
Bright Supply, Inc.12%
Young Innovations, Inc.12%

Company = labeler of record on GUDID. 21 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

MonoartCotton Roll Holderstop cardDarby Dental Supply, LLCBritedentPlasdentDefendPureLife+ Cotton Tip ApplicatorsPureLife+ Cotton RollsJMUScott's Select Cotton RollsHealth-Tec/DHP Cotton RollsGingi-Plain Cotton CoilEssentials by 3D DentaliSmileHouse Brand Dentistry

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

FDA product codes

CodeNameDevices
EFNCOTTON, ROLL27
EFNCotton, Roll18
DZNInstruments, Dental Hand9
KHRAbsorber, Saliva, Paper5
NABGauze / Sponge,Nonresorbable For External Use4
NABGauze / sponge,nonresorbable for external use2

GMDN & GCC registration

  • GMDN code 31815 · non‑implantable
  • Single‑use 96% · sterile 4% · Rx‑only 6% · OTC 6%
  • 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) · 1Outer Diameter (Inch) · 1

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

How many dental cotton roll products are registered in the US?

52 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental cotton roll", from 21 companies. The largest labeler is Polydentia Sa with 17% of records.

Which FDA product codes apply?

EFN (COTTON, ROLL), EFN (Cotton, Roll), DZN (Instruments, Dental Hand), KHR (Absorber, Saliva, Paper)

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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