Product code EJX
- Device name
- Anchor, Preformed
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.3130
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K133088 | ZX-27 | M&M Dental Studio, Inc. | 2015-01-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| D990SFA10PKDKOA0 | Separable Fastener Assembly 10PK - Drill Kit Included, Omnibut | SMART DENTURE CONVERSIONS, LLC | 2025-05-19 |
| D990RKPOCOA0 | Recharge Kit w/ POC, Omnibut | SMART DENTURE CONVERSIONS, LLC | 2025-05-19 |
| D990RKOA0 | Recharge Kit w/ Tall Spare Parts, Omnibut | SMART DENTURE CONVERSIONS, LLC | 2025-05-19 |
| D990PTB1PKOA0 | Pre-Coated TiBase 1PK, Omnibut | SMART DENTURE CONVERSIONS, LLC | 2025-05-19 |
| D990PTB1PKIT0 | Pre-Coated TiBase 1PK, Integrated Thread | SMART DENTURE CONVERSIONS, LLC | 2025-05-19 |
| D990PTB1PKEX0 | Pre-Coated TiBase 1PK, Ext. Thread | SMART DENTURE CONVERSIONS, LLC | 2025-05-19 |
| D990PTB1PK0 | Pre-Coated TiBase 1PK | SMART DENTURE CONVERSIONS, LLC | 2025-05-19 |
| D990PTB10PKIT0 | Pre-Coated TiBase 10PK, Integrated Thread | SMART DENTURE CONVERSIONS, LLC | 2025-05-19 |
| D990PTB10PKEX0 | Pre-Coated TiBase 10PK, Ext. Thread | SMART DENTURE CONVERSIONS, LLC | 2025-05-19 |
| D990RKST0 | Recharge Kit, Straumann | SMART DENTURE CONVERSIONS, LLC | 2022-12-26 |
| D990KDTLPSK0 | Premium Starter Kit, TiLobe (Quad Drive) | SMART DENTURE CONVERSIONS, LLC | 2022-12-26 |
| D990KDIHPSK0 | Premium Starter Kit, Paltop (IHex) | SMART DENTURE CONVERSIONS, LLC | 2022-12-26 |
| D990BHHDPSK0 | Premium Starter Kit, BioHorizons | SMART DENTURE CONVERSIONS, LLC | 2022-12-26 |
| H66818100351 | Keystone Industries | Keystone Industries | 2022-11-30 |
| H66818100451 | Keystone Industries | Keystone Industries | 2022-11-30 |
| H66818000861 | Keystone Industries | Keystone Industries | 2022-11-30 |
| H66818000851 | Keystone Industries | Keystone Industries | 2022-11-30 |
| H66818000351 | Keystone Industries | Keystone Industries | 2022-11-30 |
| H66818000251 | Keystone Industries | Keystone Industries | 2022-11-30 |
| H66811100401 | Keystone Industries | Keystone Industries | 2022-11-30 |
| H66811100301 | Keystone Industries | Keystone Industries | 2022-11-30 |
| H66811100201 | Keystone Industries | Keystone Industries | 2022-11-30 |
| H66811100101 | Keystone Industries | Keystone Industries | 2022-11-30 |
| 07640166513759 | Dalbo®-PLUS /-Classic /-B /-Z | Cendres+Métaux SA | 2021-09-23 |
| 07640173091684 | Dalbo®-Z | Cendres+Métaux SA | 2021-01-08 |
| 07640166511175 | CM LOC® | Cendres+Métaux SA | 2019-02-22 |
| 07640166511168 | CM LOC® | Cendres+Métaux SA | 2018-06-20 |
| 07640166511182 | CM LOC® | Cendres+Métaux SA | 2018-06-20 |
| 08435389802624 | FEMALE OF DAL-BO STANDARD ABUTMENT | BIOTECHNOLOGY INSTITUTE SL | 2015-10-17 |
| 08435389802617 | FEMALE OF DAL-BO PLUS ABUTMENT | BIOTECHNOLOGY INSTITUTE SL | 2015-10-17 |