| Primary Device ID | 00815619020185 |
| NIH Device Record Key | ed0b5fbe-43ea-4b2e-a898-f64951b82001 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EXACTA Flow-lc |
| Version Model Number | Shade A3 |
| Catalog Number | 1-EFA3 |
| Company DUNS | 016325552 |
| Company Name | EXACTA DENTAL PRODUCTS 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815619020185 [Primary] |
| EBC | Sealant, Pit And Fissure, And Conditioner |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-11-19 |
| Device Publish Date | 2018-10-17 |
| 00815619020222 | 2g syringe of flowable composite for dental restorations. |
| 00815619020215 | 2g syringe of flowable composite for dental restorations. |
| 00815619020208 | 2g syringe of flowable composite for dental restorations. |
| 00815619020192 | 2g syringe of flowable composite for dental restorations. |
| 00815619020185 | 2g syringe of flowable composite for dental restorations. |
| 00815619020178 | 2g syringe of flowable composite for dental restorations. |
| 00815619020161 | 2g syringe of flowable composite for dental restorations. |
| 00815619021526 | 2g syringe of flowable composite for dental restorations. |