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Device Explorer · FDA GUDID · GMDN 34524

Dental tooth-cleaning solution

A liquid or gel substance intended to be applied by a dental professional to clean tooth surfaces/cavities, often prior to or following a dental procedure (e.g., restoration, implantation). It typically contains appropriate cleaning agents and may be formulate

US‑registered devices52in commercial distribution
Companies14labelers on GUDID
Single‑use27%of device records
Sterile0%labelled sterile
Prescription87%Rx‑only share
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Share of device records

Ultradent Products, Inc.1427%
Sage Products, Llc1019%
Vericom Co., Ltd.612%
Coltene/Whaledent Inc510%
Vista Dental48%
Edge Endo Llc36%
Peter Brasseler Holdings, Llc24%
Hsg-S Corp.24%

Top labelers

CompanyDevicesShare
Ultradent Products, Inc.1427%
Sage Products, Llc1019%
Vericom Co., Ltd.612%
Coltene/Whaledent Inc510%
Vista Dental48%
Edge Endo Llc36%
Peter Brasseler Holdings, Llc24%
Hsg-S Corp.24%
Clinician'S Choice Dental Products, Inc.12%
Cao Group, Inc.12%
Engineered Endodontics, Llc12%
Bisco Inc.12%

Company = labeler of record on GUDID. 14 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Q-CareDetail™ Pre-Impression Cleansing GelBrasseler USAConsepsisLEAP Cavity Cleansing SolutionEDTAClean & Boost Gel 5 PackClean & Boost Liquid 5 PackClean & Boost Liquid Single Syringe PackClean & Boost Gel Single Syringe PackEdgeEndo ChlohexidineEdgeEndo Sodium HypochloiteEdgeEndoCavity CleanserDENTIN DESENSITIZERCanalPro

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

FDA product codes

CodeNameDevices
JOLCATHETER AND TIP, SUCTION21
NSBPatient personal hygiene kit21
KXFAPPLICATOR, ABSORBENT TIPPED, NON-STERILE16
LBHVARNISH, CAVITY14
EKQPreparer, Root Canal Endodontic10
EBFMATERIAL, TOOTH SHADE, RESIN6

GMDN & GCC registration

  • GMDN code 34524 · non‑implantable
  • Single‑use 27% · sterile 0% · Rx‑only 87% · 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

Total Volume (Milliliter) · 3

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

How many dental tooth-cleaning solution 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 tooth-cleaning solution", from 14 companies. The largest labeler is Ultradent Products, Inc. with 27% of records.

Which FDA product codes apply?

JOL (CATHETER AND TIP, SUCTION), NSB (Patient personal hygiene kit), KXF (APPLICATOR, ABSORBENT TIPPED, NON-STERILE), LBH (VARNISH, CAVITY)

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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