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Device Explorer · FDA GUDID · GMDN 36153

Dental tooth-etching solution

An acid solution, in liquid or gel form, intended to be applied to tooth surfaces to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant; it is also referred to as dental etchant. After application, this device cannot be r

US‑registered devices535in commercial distribution
Companies81labelers on GUDID
Single‑use22%of device records
Sterile0%labelled sterile
Prescription76%Rx‑only share
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Share of device records

E Dental Products5310%
Reliance Orthodontic Products Inc316%
Bisco Inc.306%
Ultradent Products, Inc.255%
Orthosource204%
Pulpdent Corporation204%
Scientific Pharmaceuticals, Inc.194%
Dentonics Inc173%

Top labelers

CompanyDevicesShare
E Dental Products5310%
Reliance Orthodontic Products Inc316%
Bisco Inc.306%
Ultradent Products, Inc.255%
Orthosource204%
Pulpdent Corporation204%
Scientific Pharmaceuticals, Inc.194%
Dentonics Inc173%
Gc America Inc.173%
Henry Schein, Inc.163%
Dental Technologies, Inc.132%
Vericom Co., Ltd.132%

Company = labeler of record on GUDID. 81 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Total EtchMax Etch 35% Phosphoric Acid Etch 5mlMax Etch 35% Phosphoric Acid Etch 30mlMDC DentalPhosphoric Acid Etching GelHydrofluoric Acid Etching GelCeramic EtchantEna Etch ®K-ETCHANT SyringeK-ETCHANT GELHarvard EtchETCHING GELEtching GelVitiqueLuxaBond - Total EtchGC Ortho Etching Gel

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

FDA product codes

CodeNameDevices
KLEAgent, Tooth Bonding, Resin221
KLEAGENT, TOOTH BONDING, RESIN140
EBFMaterial, Tooth Shade, Resin99
EBFMATERIAL, TOOTH SHADE, RESIN49
EIDSYRINGE, RESTORATIVE AND IMPRESSION MATERIAL42
DYHAdhesive, Bracket And Tooth Conditioner, Resin37

GMDN & GCC registration

  • GMDN code 36153 · non‑implantable
  • Single‑use 22% · sterile 0% · Rx‑only 76% · OTC 1%
  • 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) · 130Weight (Gram) · 25Needle Gauge (Gauge) · 5

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

How many dental tooth-etching solution products are registered in the US?

535 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental tooth-etching solution", from 81 companies. The largest labeler is E Dental Products with 10% of records.

Which FDA product codes apply?

KLE (Agent, Tooth Bonding, Resin), KLE (AGENT, TOOTH BONDING, RESIN), EBF (Material, Tooth Shade, Resin), EBF (MATERIAL, TOOTH SHADE, RESIN)

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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