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Device Explorer · FDA GUDID · GMDN 45232

Dental coating, tooth-desensitizing

A substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and physiological agents (e.g., cold, heat, contact, acid, bruxism) by forming

US‑registered devices300in commercial distribution
Companies31labelers on GUDID
Single‑use74%of device records
Sterile0%labelled sterile
Prescription70%Rx‑only share
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Share of device records

Young Dental Manufacturing I, Llc5418%
Nanova Bio Materials Inc5017%
Henry Schein, Inc.217%
Voco Gmbh207%
Preventech207%
Elevate Oral Care, Llc165%
Darby Dental Supply, Llc155%
Gc America Inc.155%

Top labelers

CompanyDevicesShare
Young Dental Manufacturing I, Llc5418%
Nanova Bio Materials Inc5017%
Henry Schein, Inc.217%
Voco Gmbh207%
Preventech207%
Elevate Oral Care, Llc165%
Darby Dental Supply, Llc155%
Gc America Inc.155%
Benco Dental Supply Co.124%
Ultradent Products, Inc.114%
Dmg America, Llc103%
Den-Mat Holdings, Llc93%

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

Brand names on the register (sample)

TEETHMATE™ DESENSITIZERTokuyama Shield Force PlusISODANVOCO Profluorid VarnishProfluorid LDarby Dental Supply, LLCUniversal Dentin SealantEnamelastUltraEZHemaseal & Cide - UnidoseHemaseal & CideFluoriMax 2.5% NaF demo packFluoriMax 2.5% NaF Varnish Flow ThroughFluoriMax Salted CaramelFluoriMax 2.5% NaF Varnish ThroughAdvantage Arrest

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

FDA product codes

CodeNameDevices
LBHVarnish, Cavity160
LBHVARNISH, CAVITY124
KLEAgent, Tooth Bonding, Resin18
EJKLiner, Cavity, Calcium Hydroxide7
EJRAGENT, POLISHING, ABRASIVE, ORAL CAVITY7
KLEAGENT, TOOTH BONDING, RESIN6

GMDN & GCC registration

  • GMDN code 45232 · non‑implantable
  • Single‑use 74% · sterile 0% · Rx‑only 70% · 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

Total Volume (Milliliter) · 43

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

How many dental coating, tooth-desensitizing products are registered in the US?

300 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental coating, tooth-desensitizing", from 31 companies. The largest labeler is Young Dental Manufacturing I, Llc with 18% of records.

Which FDA product codes apply?

LBH (Varnish, Cavity), LBH (VARNISH, CAVITY), KLE (Agent, Tooth Bonding, Resin), EJK (Liner, Cavity, Calcium Hydroxide)

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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