Dycal® Radiopaque Calcium Hydroxide Composition 623117
GUDID D0026231170
Dycal® Placement Instrument Refill
DENTSPLY INTERNATIONAL INC.
Calcium hydroxide dental cement| Primary Device ID | D0026231170 |
| NIH Device Record Key | 5d4ed41f-8bb5-4d24-9071-9ebb7ea27b05 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dycal® Radiopaque Calcium Hydroxide Composition |
| Version Model Number | 623117 |
| Catalog Number | 623117 |
| Company DUNS | 083235549 |
| Company Name | DENTSPLY INTERNATIONAL INC. |
| Device Count | 12 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| 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 |
| MilfordDE-Customer-Service@dentsplysirona.com | |
| Phone | +1(800)532-2855 |
| MilfordDE-Customer-Service@dentsplysirona.com | |
| Phone | +1(800)532-2855 |
| MilfordDE-Customer-Service@dentsplysirona.com | |
| Phone | +1(800)532-2855 |
| MilfordDE-Customer-Service@dentsplysirona.com | |
| Phone | +1(800)532-2855 |
| MilfordDE-Customer-Service@dentsplysirona.com | |
| Phone | +1(800)532-2855 |
| MilfordDE-Customer-Service@dentsplysirona.com | |
| Phone | +1(800)532-2855 |
| MilfordDE-Customer-Service@dentsplysirona.com | |
| Phone | +1(800)532-2855 |
| MilfordDE-Customer-Service@dentsplysirona.com | |
| Phone | +1(800)532-2855 |
| MilfordDE-Customer-Service@dentsplysirona.com | |
| Phone | +1(800)532-2855 |
| MilfordDE-Customer-Service@dentsplysirona.com | |
| Phone | +1(800)532-2855 |
| MilfordDE-Customer-Service@dentsplysirona.com | |
| Phone | +1(800)532-2855 |
| MilfordDE-Customer-Service@dentsplysirona.com | |
| Phone | +1(800)532-2855 |
| MilfordDE-Customer-Service@dentsplysirona.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D0026231170 [Unit of Use] |
| HIBCC | D0026231171 [Primary] |
FDA Product Code
| DZN | INSTRUMENTS, DENTAL HAND |
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 |
On-Brand Devices [Dycal® Radiopaque Calcium Hydroxide Composition]
| D002623401Y1 | Dycal® Radiopaque Calcium Hydroxide Composition - Export Package - Ivory |
| D002611066061 | Dycal® in Tubes, ECO (6-Packs) - Shade Dentin |
| D002611065011 | Dycal® in Tubes, Standard Pack - Shade Dentin |
| D002611056061 | Dycal® in Tubes, ECO (6-Packs) - Shade Ivory |
| D002611055011 | Dycal® in Tubes, Standard Pack - Shade Ivory |
| D0026231170 | Dycal® Placement Instrument Refill |
| D0026234501 | Dycal® Radiopaque Calcium Hydroxide Composition Complete Package - Dentin Shade |
| D0026234001 | Dycal® Radiopaque Calcium Hydroxide Composition Complete Package - Ivory Shade |
Trademark Results [Dycal]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DYCAL 72101309 0718307 Live/Registered |
L. D. Caulk Company, The 1960-07-22 |
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