| Primary Device ID | 00850440008490 |
| NIH Device Record Key | f4a8bf13-1ae3-48a9-9481-bd8ceafbb31b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Actacal Bioceramic Sealer |
| Version Model Number | ACS |
| Company DUNS | 079892178 |
| Company Name | Engineered Endodontics, LLC |
| 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850440008490 [Primary] |
| KIF | Resin, Root Canal Filling |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-12 |
| Device Publish Date | 2026-01-02 |
| 00850440008001 - TUN Ultrasonic Tip | 2026-01-12 TUN Ultrasonic Tip |
| 00850440008025 - TUN Ultrasonic Tip | 2026-01-12 TUN Ultrasonic Tip |
| 00850440008049 - TUN Ultrasonic Tip | 2026-01-12 TUN Ultrasonic Tip |
| 00850440008063 - TUN Ultrasonic Tip | 2026-01-12 TUN Ultrasonic Tip |
| 00850440008087 - TUN Ultrasonic Tip | 2026-01-12 TUN Ultrasonic Tip |
| 00850440008100 - TUN Ultrasonic Tip | 2026-01-12 TUN Ultrasonic Tip |
| 00850440008124 - Finishing File | 2026-01-12 FIle intended to draw irrigation solution to the apex of the root canal to flush the entire canal. |
| 00850440008131 - Finishing File | 2026-01-12 File intended to draw irrigation solution to the apex of the root canal to flush the entire canal. |