Dycal® Radiopaque Calcium Hydroxide Composition

FDA UDI

by Dentsply International

Identity

Trade Name: Dycal® Radiopaque Calcium Hydroxide Composition FDA UDI
Generic Name: Calcium hydroxide dental cement FDA UDI
Device Name: Dycal® in Tubes, ECO (6-Packs) - Shade Ivory FDA UDI
Model / Reference: 61105606 FDA UDI
Description: Dycal® in Tubes, ECO (6-Packs) - Shade Ivory FDA UDI

Identifiers

Catalog Number: 61105606 FDA UDI
Primary DI / UDI-DI: D002611056061 FDA UDI
510(k) Number: K780384 FDA UDI
GMDN Term: Calcium hydroxide dental cement FDA UDI

Classification

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

Category: Calcium hydroxide dental cement

Dycal® Radiopaque Calcium Hydroxide Composition by Dentsply International — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K780384 also covers:

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	N/A	Pending data

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Manufacturer

Manufacturer: Dentsply International

Sources (1)

FDA UDI cfa2683b-365d-4ff6-b2cd-f52388105539 37 fields · synced May 30, 2026