Accelx Implant System
Biotech Dental, LLC
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1824362 | 1824362 | BIOTEC, INC. | 1 | N | 2026-01-01 | 652 EAST MAIN ST. ZEELAND MI US 49464 |
| 3010730876 | 3010730876 | Biotech Dental | 1 | Y | 2026-01-01 | 145 Cedar Lane Suite 205 Englewood NJ US 07631 |
| 3010781586 | 3010781586 | BIOTECH, INC. | 1 | N | 2026-01-01 | 5975 Shiloh Rd Ste 101 Alpharetta GA US 30005 |
| 3014701704 | 3014701704 | Biotech Dental Smilers, SAS | 1 | N | 2026-01-01 | 167 impasse Gaspard Monge Salon-de-Provence Bouches-du-Rhone FR 13300 |
| 3017882410 | 3017882410 | BIOTECNO INDUSTRIA E COMERCIO LTDA | 1 | N | 2026-01-01 | Rua PIRAPO 613,TIMBAUVA SANTA ROSA Rio Grande do Sul BR 98781-054 |
| 3013561882 | 3013561882 | BIOTEC BETAGLUCANS AS | 1 | N | 2020-04-25 | Sykehusveien 23 Tromsoe Troms NO 9294 |
| 3016685789 | 3016685789 | BIOTECH INNOVA | 1 | N | 2020-04-25 | 9558 Clint Moore Rd Boca Raton FL US 33496 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 300493 | 1972316856 | K213997 | Kontact Dental Implant System | DZE | 2022-07-15 |
| 301597 | 1080411306 | K212961 | SMILERS | NXC | 2021-09-20 |
| 300493 | 1309634400 | K212961 | SMILERS | NXC | 2021-09-20 |
| 300493 | 1178531394 | K210220 | Kontact Dental Implant System | DZE | 2021-06-18 |
| 300493 | 1430098170 | K180924 | Reflect Implant System | DZE | 2019-03-29 |
| 167293 | 1894250525 | K122982 | CRYOLOCK | MQK | 2014-01-09 |
| 251292 | 1812661251 | ||||
| 206211 | 1931801621 | ||||
| 33192 | 1124627300 | ||||
| 300493 | 1153893481 | ||||
| 300493 | 1249720307 | ||||
| 301597 | 1356172105 | ||||
| 286173 | 1395093656 | ||||
| 301597 | 1729681893 | ||||
| 300493 | 1786557248 | ||||
| 300493 | 1906263944 | ||||
| 300493 | 2008839297 | ||||
| 301597 | 2022620883 |
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