Dycal Radiopaque Calcium Hydroxide 623451Y

GUDID D002623451Y1

Dycal® Radiopaque Calcium Hydroxide Composition - Export Package - Dentin

DENTSPLY INTERNATIONAL INC.

Calcium hydroxide dental cement
Primary Device IDD002623451Y1
NIH Device Record Key42a2d9be-12cb-4bee-8e0e-90f4d3efcb3d
Commercial Distribution StatusIn Commercial Distribution
Brand NameDycal Radiopaque Calcium Hydroxide
Version Model Number623451Y
Catalog Number623451Y
Company DUNS083235549
Company NameDENTSPLY INTERNATIONAL INC.
Device Count1
DM Exemptfalse
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 Latextrue
RX Perscriptionfalse
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
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

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.
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
HIBCCD002623451Y1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-14
Device Publish Date2022-04-06

Devices Manufactured by DENTSPLY INTERNATIONAL INC.

D0031000072190 - Schick2024-11-14 AE SENSOR REPLACEABLE CABLE KIT, 6FT
D0031000072200 - Schick2024-11-14 AE SENSOR REPLACEABLE CABLE KIT, 9FT
D0031000072210 - Schick2024-11-14 AE SENSOR REPLACEABLE CABLE KIT, 3FT
D0031000082860 - Schick2024-11-14 SCHICK 33 USB 3.0 Package
D0031000082900 - Schick2024-11-14 SCHICK 33 USB 3.0 Package, RMA
D0031000085860 - Schick2024-11-14 SCHICK33 S2 SENSOR, 9FT FOR DSO
D0031000085870 - Schick2024-11-14 SCHICK33 S1 SENSOR, 9FT FOR DSO
D0031000085880 - Schick2024-11-14 SCHICK33 S0 SENSOR, 9FT FOR DSO
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.