Dycal Radiopaque Calcium Hydroxide 623451Y

GUDID D002623451Y1

Dycal® Radiopaque Calcium Hydroxide Composition - Export Package - Dentin

DENTSPLY INTERNATIONAL INC.

Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement

• Primary Device ID: D002623451Y1
• NIH Device Record Key: 42a2d9be-12cb-4bee-8e0e-90f4d3efcb3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dycal Radiopaque Calcium Hydroxide
• Version Model Number: 623451Y
• Catalog Number: 623451Y
• Company DUNS: 083235549
• Company Name: DENTSPLY INTERNATIONAL INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D002623451Y1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K780384

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-14
• Device Publish Date: 2022-04-06

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