Delton®

FDA UDI

Class II (US FDA UDI)

by Dentsply Professional

Identity

Trade Name: DELTON® FDA UDI
Generic Name: Cable/lead/sensor/probe cover, non-sterile FDA UDI
Device Name: DELTON® FS+ FLOWABLE Pit & Fissure Sealant with FLUORIDE Light Curing Opaque. Also contains: Delton® Syringes, EZ Etch Syringe, EZ Tips, and Syringe Sleeves. FDA UDI
Model / Reference: 310101 FDA UDI
Description: DELTON® FS+ FLOWABLE Pit & Fissure Sealant with FLUORIDE Light Curing Opaque. Also contains: Delton® Syringes, EZ Etch Syringe, EZ Tips, and Syringe Sleeves. FDA UDI

Identifiers

Primary DI / UDI-DI: D0033101011 FDA UDI
FDA Product Code: EBC FDA UDI
PEM FDA UDI
EFB FDA UDI
GMDN Term: Cable/lead/sensor/probe cover, non-sterile FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3765 FDA UDI
878.4370 FDA UDI
872.4200 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

Yes

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

Dimensions & Sizes

Size: Weight — 1.9 Gram FDA UDI

Category: Dental composite resin Cable/lead/sensor/probe cover, non-sterile

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

Similar devices

Also classified as Cable/lead/sensor/probe cover, non-sterile.

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Pinnacle X-Ray Sensor Sheaths — METREX RESEARCH · Class II
RINN® — Dentsply International · Class II
Pinnacle X-Ray Sensor Sheath — METREX RESEARCH · Class II
MICROTEK — Microtek Medical LLC · Class II
RINN® — Dentsply International · 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 0277a859-b62b-4d52-97d4-187f4767d9c8 36 fields · synced May 30, 2026