Consulting Wallah › Device Explorer › Dental › Dental pit/fissure sealant
Device Explorer · FDA GUDID · GMDN 31780

Dental pit/fissure sealant

A resin-based dental material suitable for sealing pits and fissures on teeth. It may be chemically cured or external energy cured. After application, this device cannot be reused.

US‑registered devices247in commercial distribution
Companies24labelers on GUDID
Single‑use17%of device records
Sterile0%labelled sterile
Prescription91%Rx‑only share
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Share of device records

Sdi Limited11848%
Scientific Pharmaceuticals, Inc.3113%
Ultradent Products, Inc.135%
Denali Corporation125%
Pulpdent Corporation125%
Dental Technologies, Inc.73%
Dentonics Inc73%
Patterson Dental Supply, Inc.73%

Top labelers

CompanyDevicesShare
Sdi Limited11848%
Scientific Pharmaceuticals, Inc.3113%
Ultradent Products, Inc.135%
Denali Corporation125%
Pulpdent Corporation125%
Dental Technologies, Inc.73%
Dentonics Inc73%
Patterson Dental Supply, Inc.73%
Dmg Chemisch-Pharmazeutische Fabrik Gmbh62%
Harry J Bosworth Company62%
Iq Dental Supply Llc42%
Pearson Dental Supplies, Inc.31%

Company = labeler of record on GUDID. 24 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Constic OWConstic B1Constic A3.5Constic A3Constic A2Constic A1PREVENT SEALDarby Dental Supply, LLCAURAROKICEWAVESHADECONSEALGLACIERClone Bite

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

FDA product codes

CodeNameDevices
EBFMATERIAL, TOOTH SHADE, RESIN119
EBCSealant, Pit And Fissure, And Conditioner85
EBCSEALANT, PIT AND FISSURE, AND CONDITIONER21
EBFMaterial, Tooth Shade, Resin14
DYHADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN5
EBDCoating, Filling Material, Resin2

GMDN & GCC registration

  • GMDN code 31780 · non‑implantable
  • Single‑use 17% · sterile 0% · Rx‑only 91% · 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) · 18Weight (Gram) · 6Needle Gauge (Gauge) · 2

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

How many dental pit/fissure sealant products are registered in the US?

247 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental pit/fissure sealant", from 24 companies. The largest labeler is Sdi Limited with 48% of records.

Which FDA product codes apply?

EBF (MATERIAL, TOOTH SHADE, RESIN), EBC (Sealant, Pit And Fissure, And Conditioner), EBC (SEALANT, PIT AND FISSURE, AND CONDITIONER), 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.

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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