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Device Explorer · FDA GUDID · GMDN 35698

Dental cavity varnish

A liquid substance used in dentistry consisting of one or more resins in an organic solvent, used for the protection of pulpal tissue and to provide a marginal seal to newly placed amalgam restorations. After application, this device cannot be reused.

US‑registered devices234in commercial distribution
Companies31labelers on GUDID
Single‑use82%of device records
Sterile1%labelled sterile
Prescription76%Rx‑only share
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Share of device records

Dentsply Professional3415%
3M Company3113%
Centrix, Inc.2812%
Scientific Pharmaceuticals, Inc.2712%
Taub Products115%
Cargus International, Inc115%
Roses And Rubies, Llc104%
Premier Dental Products Company104%

Top labelers

CompanyDevicesShare
Dentsply Professional3415%
3M Company3113%
Centrix, Inc.2812%
Scientific Pharmaceuticals, Inc.2712%
Taub Products115%
Cargus International, Inc115%
Roses And Rubies, Llc104%
Premier Dental Products Company104%
Vericom Co., Ltd.94%
Benco Dental Supply Co.73%
Pascal Company, Inc.63%
Dentonics Inc52%

Company = labeler of record on GUDID. 31 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Tokuyama Shield Force PlusGo-CHx Gel - 0.8% ChlorhexidineHydroxylineResolve Cleansing GelCariFreeWonderful DentalSciPharm Fluoroseal Cavity LinerSciPharm Copal Cavity VarnishInternational Dental Supply Fluoroseal Cavity LiMARK3Stern Vantage® Varnish LC 5.0ml bottleDental CityALPHA-DENT® Cavity VarnishVivid Copal Varnish3D Dental-Dream3D Dental - Dream

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

FDA product codes

CodeNameDevices
LBHVarnish, Cavity221
LBHVARNISH, CAVITY97
EJKLiner, Cavity, Calcium Hydroxide8
PMEExternal Cleaning Solution4
KLEAGENT, TOOTH BONDING, RESIN2
EBIResin, Denture, Relining, Repairing, Rebasing1

GMDN & GCC registration

  • GMDN code 35698 · non‑implantable
  • Single‑use 82% · sterile 1% · Rx‑only 76% · OTC 3%
  • 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) · 46Weight (Gram) · 29

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

How many dental cavity varnish products are registered in the US?

234 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental cavity varnish", from 31 companies. The largest labeler is Dentsply Professional with 15% of records.

Which FDA product codes apply?

LBH (Varnish, Cavity), LBH (VARNISH, CAVITY), EJK (Liner, Cavity, Calcium Hydroxide), PME (External Cleaning Solution)

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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