Dycal® Dentin Radiopaque Calcium Hydroxide Composition 623702

GUDID D0026237021

Dycal® Radiopaque Calcium Hydroxide Composition Tube Refill Package - Dentin Shade

DENTSPLY INTERNATIONAL INC.

Dental composite resin

• Primary Device ID: D0026237021
• NIH Device Record Key: 957d4dcc-af33-44dc-826d-c7b268212dfe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dycal® Dentin Radiopaque Calcium Hydroxide Composition
• Version Model Number: 623702
• Catalog Number: 623702
• Company DUNS: 083235549
• Company Name: DENTSPLY INTERNATIONAL INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• RX Perscription: true
• 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

Device Dimensions

• Weight: 13 Gram
• Weight: 11 Gram
• Device Size Text, specify: 0
• Weight: 13 Gram
• Weight: 11 Gram
• Device Size Text, specify: 0
• Weight: 13 Gram
• Weight: 11 Gram
• Device Size Text, specify: 0
• Weight: 13 Gram
• Weight: 11 Gram
• Device Size Text, specify: 0
• Weight: 13 Gram
• Weight: 11 Gram
• Device Size Text, specify: 0
• Weight: 13 Gram
• Weight: 11 Gram
• Device Size Text, specify: 0
• Weight: 13 Gram
• Weight: 11 Gram
• Device Size Text, specify: 0
• Weight: 13 Gram
• Weight: 11 Gram
• Device Size Text, specify: 0
• Weight: 13 Gram
• Weight: 11 Gram
• Device Size Text, specify: 0
• Weight: 13 Gram
• Weight: 11 Gram
• Device Size Text, specify: 0
• Weight: 13 Gram
• Weight: 11 Gram
• Device Size Text, specify: 0
• Weight: 13 Gram
• Weight: 11 Gram
• Device Size Text, specify: 0
• Weight: 13 Gram
• Weight: 11 Gram
• Device Size Text, specify: 0
• Weight: 13 Gram
• Weight: 11 Gram
• Device Size Text, specify: 0
• Weight: 13 Gram
• Weight: 11 Gram
• Device Size Text, specify: 0
• Weight: 13 Gram
• Weight: 11 Gram
• Device Size Text, specify: 0
• Weight: 13 Gram
• Weight: 11 Gram
• Device Size Text, specify: 0

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.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D0026237021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K780384

FDA Product Code

• EJK: LINER, CAVITY, CALCIUM HYDROXIDE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-08-31
• Device Publish Date: 2016-09-23

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

• D0026237021: Dycal® Radiopaque Calcium Hydroxide Composition Tube Refill Package - Dentin Shade
• D00262380262: Dycal® Dentin Radiopaque Calcium Hydroxide Composition, Standard Package