| Primary Device ID | 00889989074154 |
| NIH Device Record Key | 01534921-cee1-45d6-bac6-7721e26ef8e2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pulp Canal Sealer |
| Version Model Number | 24873 |
| Company DUNS | 154614119 |
| Company Name | ORMCO CORPORATION |
| Device Count | 4 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +18005377123 |
| EndoRotaryCustCare@kerrdental.com | |
| Phone | +18005377123 |
| EndoRotaryCustCare@kerrdental.com | |
| Phone | +18005377123 |
| EndoRotaryCustCare@kerrdental.com | |
| Phone | +18005377123 |
| EndoRotaryCustCare@kerrdental.com | |
| Phone | +18005377123 |
| EndoRotaryCustCare@kerrdental.com | |
| Phone | +18005377123 |
| EndoRotaryCustCare@kerrdental.com | |
| Phone | +18005377123 |
| EndoRotaryCustCare@kerrdental.com | |
| Phone | +18005377123 |
| EndoRotaryCustCare@kerrdental.com | |
| Phone | +18005377123 |
| EndoRotaryCustCare@kerrdental.com | |
| Phone | +18005377123 |
| EndoRotaryCustCare@kerrdental.com | |
| Phone | +18005377123 |
| EndoRotaryCustCare@kerrdental.com | |
| Phone | +18005377123 |
| EndoRotaryCustCare@kerrdental.com | |
| Phone | +18005377123 |
| EndoRotaryCustCare@kerrdental.com | |
| Phone | +18005377123 |
| EndoRotaryCustCare@kerrdental.com |
| Total Volume | 16 Milliliter |
| Total Volume | 16 Milliliter |
| Total Volume | 16 Milliliter |
| Total Volume | 16 Milliliter |
| Total Volume | 16 Milliliter |
| Total Volume | 16 Milliliter |
| Total Volume | 16 Milliliter |
| Total Volume | 16 Milliliter |
| Total Volume | 16 Milliliter |
| Total Volume | 16 Milliliter |
| Total Volume | 16 Milliliter |
| Total Volume | 16 Milliliter |
| Total Volume | 16 Milliliter |
| Special Storage Condition, Specify | Between 0 and 0 *Store at ambient temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at ambient temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at ambient temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at ambient temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at ambient temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at ambient temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at ambient temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at ambient temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at ambient temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at ambient temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at ambient temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at ambient temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at ambient temperature. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889989074154 [Primary] |
| GS1 | 10889989073116 [Unit of Use] |
| KIF | RESIN, ROOT CANAL FILLING |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2026-02-11 |
| Device Publish Date | 2016-09-08 |
| 00889989074178 | Root Canal Sealer (1 - Jar (10.5g), 1 - Bottle (4mL) |
| 00889989074161 | Powder Refill - Root Canal Sealer (Jar, 10.5g each) |
| 00889989074154 | Liquid Refill - Root Canal Sealer (Bottle, 4mL each) |