| Primary Device ID | D861D650 |
| NIH Device Record Key | a2e008cc-2459-404e-a2b7-9b2ee96fe160 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TPC |
| Version Model Number | D650N |
| Catalog Number | D650 |
| Company DUNS | 968884275 |
| Company Name | TPC ADVANCE TECHNOLOGY, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Manufacturing Date | true |
| 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 | 626-810-4337 |
| sbeckley@tpcdental.com | |
| Phone | 626-810-4337 |
| sbeckley@tpcdental.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D861D650 [Primary] |
| EFD | Amalgamator, Dental, Ac-Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-09-24 |
| Device Publish Date | 2018-08-22 |
| D861PM250 | scaler to remove calculus |
| D861PL1500 | Halogen light cure |
| D861PL1000 | Halogen light cure. |
| D861LED39N0 | LED 39N light cure. |
| D861D650 | Digital dental amalgamator used for mixing dental amalgam. |
| D861ALED70N0 | LED light cure |
| D861ALED60N0 | LED light cure |
| D861ALED55N0 | LED light cure |
| D861ALED55BN0 | LED Built In Curing Light |
| D861ALED500 | LED light cure |
| D861ALED25000 | LED light cure |
| D861A850LED0 | A850LED |
| D861A800N0 | scaler to remove calculus |
| D861A800LED0 | scaler to remove calculus |
| D861A750N0 | scaler to remove calculus |
| D861A750LED0 | scaler with led to remove calculus |