Dycal® Ivory Radiopaque Calcium Hydroxide Composition 623801

GUDID D00262380162

Dycal® Ivory Radiopaque Calcium Hydroxide Composition, Standard Package

DENTSPLY INTERNATIONAL INC.

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Primary Device IDD00262380162
NIH Device Record Keyf023a18c-3076-4976-b0ec-78cbcbfe4819
Commercial Distribution StatusIn Commercial Distribution
Brand NameDycal® Ivory Radiopaque Calcium Hydroxide Composition
Version Model Number623801
Catalog Number623801
Company DUNS083235549
Company NameDENTSPLY INTERNATIONAL INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com

Device Dimensions

Device Size Text, specify0
Weight11 Gram
Weight13 Gram
Device Size Text, specify0
Weight11 Gram
Weight13 Gram
Device Size Text, specify0
Weight11 Gram
Weight13 Gram
Device Size Text, specify0
Weight11 Gram
Weight13 Gram
Device Size Text, specify0
Weight11 Gram
Weight13 Gram
Device Size Text, specify0
Weight11 Gram
Weight13 Gram
Device Size Text, specify0
Weight11 Gram
Weight13 Gram
Device Size Text, specify0
Weight11 Gram
Weight13 Gram
Device Size Text, specify0
Weight11 Gram
Weight13 Gram
Device Size Text, specify0
Weight11 Gram
Weight13 Gram
Device Size Text, specify0
Weight11 Gram
Weight13 Gram
Device Size Text, specify0
Weight11 Gram
Weight13 Gram
Device Size Text, specify0
Weight11 Gram
Weight13 Gram
Device Size Text, specify0
Weight11 Gram
Weight13 Gram
Device Size Text, specify0
Weight11 Gram
Weight13 Gram
Device Size Text, specify0
Weight11 Gram
Weight13 Gram
Device Size Text, specify0
Weight11 Gram
Weight13 Gram

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight.

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD0026238011 [Primary]
HIBCCD00262380162 [Package]
Contains: D0026238011
Package: [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EJKLINER, CAVITY, CALCIUM HYDROXIDE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-10-04
Device Publish Date2016-09-23

On-Brand Devices [Dycal® Ivory Radiopaque Calcium Hydroxide Composition]

D0026237011Dycal® Radiopaque Calcium Hydroxide Composition Tube Refill Package - Ivory Shade
D00262380162Dycal® Ivory Radiopaque Calcium Hydroxide Composition, Standard Package

Trademark Results [Dycal]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DYCAL
DYCAL
72101309 0718307 Live/Registered
L. D. Caulk Company, The
1960-07-22
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