| Primary Device ID | D00116936UT2443F0 |
| NIH Device Record Key | b2710fae-cb43-4aca-a784-c3b82dd711c9 |
| Commercial Distribution Discontinuation | 2022-05-05 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Trublend® SLM® Anteriors |
| Version Model Number | T24 U 43F |
| Catalog Number | 16936 |
| Company DUNS | 606173334 |
| Company Name | Dentsply International Inc. |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +1(800)243-1942 |
| Prosthetics-Regulatory@dentsplysirona.com | |
| Phone | +1(800)243-1942 |
| Prosthetics-Regulatory@dentsplysirona.com | |
| Phone | +1(800)243-1942 |
| Prosthetics-Regulatory@dentsplysirona.com | |
| Phone | +1(800)243-1942 |
| Prosthetics-Regulatory@dentsplysirona.com | |
| Phone | +1(800)243-1942 |
| Prosthetics-Regulatory@dentsplysirona.com | |
| Phone | +1(800)243-1942 |
| Prosthetics-Regulatory@dentsplysirona.com | |
| Phone | +1(800)243-1942 |
| Prosthetics-Regulatory@dentsplysirona.com | |
| Phone | +1(800)243-1942 |
| Prosthetics-Regulatory@dentsplysirona.com | |
| Phone | +1(800)243-1942 |
| Prosthetics-Regulatory@dentsplysirona.com | |
| Phone | +1(800)243-1942 |
| Prosthetics-Regulatory@dentsplysirona.com | |
| Phone | +1(800)243-1942 |
| Prosthetics-Regulatory@dentsplysirona.com | |
| Phone | +1(800)243-1942 |
| Prosthetics-Regulatory@dentsplysirona.com | |
| Phone | +1(800)243-1942 |
| Prosthetics-Regulatory@dentsplysirona.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D00116936UT2443F0 [Primary] |
| ELM | Denture, plastic, teeth |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2022-05-06 |
| Device Publish Date | 2016-10-10 |