Dentsply Sirona 634402

GUDID D0026344020

Amalgam Bonding Accessory Kit

DENTSPLY INTERNATIONAL INC.

Dentine bonding agent/set

• Primary Device ID: D0026344020
• NIH Device Record Key: 3c4985b4-9bda-4c50-babe-1f1bcc92bd10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dentsply Sirona
• Version Model Number: 634402
• Catalog Number: 634402
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated storage is not required but is acceptable when not in use. Allow material to reach room temperature prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight, and store in a well-ventilated place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Amalgam Bonding Accessory Kit adhesive should be stored wiht the original caps only.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated storage is not required but is acceptable when not in use. Allow material to reach room temperature prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight, and store in a well-ventilated place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Amalgam Bonding Accessory Kit adhesive should be stored wiht the original caps only.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated storage is not required but is acceptable when not in use. Allow material to reach room temperature prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight, and store in a well-ventilated place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Amalgam Bonding Accessory Kit adhesive should be stored wiht the original caps only.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated storage is not required but is acceptable when not in use. Allow material to reach room temperature prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight, and store in a well-ventilated place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Amalgam Bonding Accessory Kit adhesive should be stored wiht the original caps only.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated storage is not required but is acceptable when not in use. Allow material to reach room temperature prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight, and store in a well-ventilated place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Amalgam Bonding Accessory Kit adhesive should be stored wiht the original caps only.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated storage is not required but is acceptable when not in use. Allow material to reach room temperature prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight, and store in a well-ventilated place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Amalgam Bonding Accessory Kit adhesive should be stored wiht the original caps only.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated storage is not required but is acceptable when not in use. Allow material to reach room temperature prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight, and store in a well-ventilated place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Amalgam Bonding Accessory Kit adhesive should be stored wiht the original caps only.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated storage is not required but is acceptable when not in use. Allow material to reach room temperature prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight, and store in a well-ventilated place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Amalgam Bonding Accessory Kit adhesive should be stored wiht the original caps only.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated storage is not required but is acceptable when not in use. Allow material to reach room temperature prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight, and store in a well-ventilated place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Amalgam Bonding Accessory Kit adhesive should be stored wiht the original caps only.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated storage is not required but is acceptable when not in use. Allow material to reach room temperature prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight, and store in a well-ventilated place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Amalgam Bonding Accessory Kit adhesive should be stored wiht the original caps only.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated storage is not required but is acceptable when not in use. Allow material to reach room temperature prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight, and store in a well-ventilated place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Amalgam Bonding Accessory Kit adhesive should be stored wiht the original caps only.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated storage is not required but is acceptable when not in use. Allow material to reach room temperature prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight, and store in a well-ventilated place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Amalgam Bonding Accessory Kit adhesive should be stored wiht the original caps only.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated storage is not required but is acceptable when not in use. Allow material to reach room temperature prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight, and store in a well-ventilated place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Amalgam Bonding Accessory Kit adhesive should be stored wiht the original caps only.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated storage is not required but is acceptable when not in use. Allow material to reach room temperature prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight, and store in a well-ventilated place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Amalgam Bonding Accessory Kit adhesive should be stored wiht the original caps only.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated storage is not required but is acceptable when not in use. Allow material to reach room temperature prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight, and store in a well-ventilated place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Amalgam Bonding Accessory Kit adhesive should be stored wiht the original caps only.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated storage is not required but is acceptable when not in use. Allow material to reach room temperature prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight, and store in a well-ventilated place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Amalgam Bonding Accessory Kit adhesive should be stored wiht the original caps only.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated storage is not required but is acceptable when not in use. Allow material to reach room temperature prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight, and store in a well-ventilated place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Amalgam Bonding Accessory Kit adhesive should be stored wiht the original caps only.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated storage is not required but is acceptable when not in use. Allow material to reach room temperature prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight, and store in a well-ventilated place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Amalgam Bonding Accessory Kit adhesive should be stored wiht the original caps only.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated storage is not required but is acceptable when not in use. Allow material to reach room temperature prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight, and store in a well-ventilated place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Amalgam Bonding Accessory Kit adhesive should be stored wiht the original caps only.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated storage is not required but is acceptable when not in use. Allow material to reach room temperature prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight, and store in a well-ventilated place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Amalgam Bonding Accessory Kit adhesive should be stored wiht the original caps only.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated storage is not required but is acceptable when not in use. Allow material to reach room temperature prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight, and store in a well-ventilated place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Amalgam Bonding Accessory Kit adhesive should be stored wiht the original caps only.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated storage is not required but is acceptable when not in use. Allow material to reach room temperature prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight, and store in a well-ventilated place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Amalgam Bonding Accessory Kit adhesive should be stored wiht the original caps only.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated storage is not required but is acceptable when not in use. Allow material to reach room temperature prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight, and store in a well-ventilated place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Amalgam Bonding Accessory Kit adhesive should be stored wiht the original caps only.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated storage is not required but is acceptable when not in use. Allow material to reach room temperature prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight, and store in a well-ventilated place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Amalgam Bonding Accessory Kit adhesive should be stored wiht the original caps only.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated storage is not required but is acceptable when not in use. Allow material to reach room temperature prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight, and store in a well-ventilated place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Amalgam Bonding Accessory Kit adhesive should be stored wiht the original caps only.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated storage is not required but is acceptable when not in use. Allow material to reach room temperature prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight, and store in a well-ventilated place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Amalgam Bonding Accessory Kit adhesive should be stored wiht the original caps only.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D0026344020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K964525

FDA Product Code

• KLE: AGENT, TOOTH BONDING, RESIN

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: 2022-08-24
• Device Publish Date: 2022-08-16

Devices Manufactured by DENTSPLY INTERNATIONAL INC.

• D00116116UP0231F0 - Portrait® IPN® Anteriors: 2024-09-12
• D00116116UP1321E0 - Portrait® IPN® Anteriors: 2024-09-12
• D00116116UP1321G0 - Portrait® IPN® Anteriors: 2024-09-12
• D00116116UP1321J0 - Portrait® IPN® Anteriors: 2024-09-12
• D00116116UP1321X0 - Portrait® IPN® Anteriors: 2024-09-12
• D00116116UP1322C0 - Portrait® IPN® Anteriors: 2024-09-12
• D00116116UP1322E0 - Portrait® IPN® Anteriors: 2024-09-12
• D00116116UP1322G0 - Portrait® IPN® Anteriors: 2024-09-12