Dycal® Radiopaque Calcium Hydroxide Composition 623450
GUDID D0026234501
Dycal® Radiopaque Calcium Hydroxide Composition Complete Package - Dentin Shade
DENTSPLY INTERNATIONAL INC.
Dental composite resin| Primary Device ID | D0026234501 |
| NIH Device Record Key | 0eb30200-cdc0-43cf-be0a-a619521f3457 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dycal® Radiopaque Calcium Hydroxide Composition |
| Version Model Number | 623450 |
| Catalog Number | 623450 |
| 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
Device Dimensions
| Weight | 13 Gram |
| Device Size Text, specify | 0 |
| Weight | 11 Gram |
| Weight | 13 Gram |
| Device Size Text, specify | 0 |
| Weight | 11 Gram |
| Weight | 13 Gram |
| Device Size Text, specify | 0 |
| Weight | 11 Gram |
| Weight | 13 Gram |
| Device Size Text, specify | 0 |
| Weight | 11 Gram |
| Weight | 13 Gram |
| Device Size Text, specify | 0 |
| Weight | 11 Gram |
| Weight | 13 Gram |
| Device Size Text, specify | 0 |
| Weight | 11 Gram |
| Weight | 13 Gram |
| Device Size Text, specify | 0 |
| Weight | 11 Gram |
| Weight | 13 Gram |
| Device Size Text, specify | 0 |
| Weight | 11 Gram |
| Weight | 13 Gram |
| Device Size Text, specify | 0 |
| Weight | 11 Gram |
| Weight | 13 Gram |
| Device Size Text, specify | 0 |
| Weight | 11 Gram |
| Weight | 13 Gram |
| Device Size Text, specify | 0 |
| Weight | 11 Gram |
| Weight | 13 Gram |
| Device Size Text, specify | 0 |
| Weight | 11 Gram |
| Weight | 13 Gram |
| Device Size Text, specify | 0 |
| Weight | 11 Gram |
| Weight | 13 Gram |
| Device Size Text, specify | 0 |
| Weight | 11 Gram |
| Weight | 13 Gram |
| Device Size Text, specify | 0 |
| Weight | 11 Gram |
| Weight | 13 Gram |
| Device Size Text, specify | 0 |
| Weight | 11 Gram |
| Weight | 13 Gram |
| Device Size Text, specify | 0 |
| Weight | 11 Gram |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D0026234501 [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® 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 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.