Delton®

FDA UDI

Class II (US FDA UDI)

by Dentsply Professional

Identity

Trade Name: DELTON® FDA UDI
Generic Name: Dental unfilled resin sealant/coating FDA UDI
Device Name: DELTON® Pit & Fissure Sealant Direct Delivery System Light Curing Clear. Contains: 50 Cartridges - 4 ml FDA UDI
Model / Reference: 2695 FDA UDI
Description: DELTON® Pit & Fissure Sealant Direct Delivery System Light Curing Clear. Contains: 50 Cartridges - 4 ml FDA UDI

Identifiers

Primary DI / UDI-DI: D00326951 FDA UDI
FDA Product Code: EBC FDA UDI
GMDN Term: Dental unfilled resin sealant/coating FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3765 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Total Volume — 4 Milliliter FDA UDI

Category: Dental unfilled resin sealant/coating

Delton® by Dentsply Professional — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Dental unfilled resin sealant/coating.

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Ribbon — TULSA DENTAL PRODUCTS LLC · Class II
UltraSeal XT Hydro — ULTRADENT PRODUCTS, INC. · Class II
Champ — CENTRIX, INC. · Class II
OptiGuard — KERR CORPORATION · Class II
OPTIGLAZE™ — Gc America Inc. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Dentsply Professional

Sources (1)

FDA UDI fc212385-a8da-4409-a691-c855a692e3ec 36 fields · synced May 30, 2026