Dycal® Radiopaque Calcium Hydroxide Composition 623400
GUDID D0026234001
Dycal® Radiopaque Calcium Hydroxide Composition Complete Package - Ivory Shade
DENTSPLY INTERNATIONAL INC.
Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin| Primary Device ID | D0026234001 |
| NIH Device Record Key | f327630b-847a-4d09-9941-f3826b9a68ff |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dycal® Radiopaque Calcium Hydroxide Composition |
| Version Model Number | 623400 |
| Catalog Number | 623400 |
| 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
| 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 |
| Weight | 13 Gram |
| 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 | D0026234001 [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 |
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