Any-Com Bulk
FDA 510(k) clearance K242713 · decided 2025-02-07
Clearance details
- K-number
- K242713
- Device name
- Any-Com Bulk
- Applicant
- Mediclus Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-09-09
- Decision date
- 2025-02-07
- Days to decision
- 151 days
- Clearance type
- Traditional
- Product code
- EBF
- Device class
- 2
- Regulation number
- 872.3690
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Cheongju-Si, KR
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Tetric plus Fill;Tetric plus Flow (K261485) | Ivoclar Vivadent, Inc. | 2026-07-01 |
| Transcend Bulk Fill Flowable Composite (K262228) | Ultradent Products, Inc. | 2026-07-01 |
| SRGC-06 (K261246) | GC America, Inc. | 2026-06-18 |
| DIAFIL (K261093) | DiaDent Group International | 2026-06-02 |
| DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g) (K261071) | DiaDent Group International | 2026-05-19 |
| Dual Core (K260805) | Vericom Co., Ltd. | 2026-05-11 |
| Grandio disc multicolor (K261357) | Voco GmbH | 2026-04-27 |
| Dura-Crown (K261356) | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-04-27 |
| Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT) (K260152) | Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. | 2026-04-23 |
| Midas Restore (K260661) | Sprintray, Inc. | 2026-04-15 |
| Light-curing Coloring Materials (ALCM) (K253036) | Aidite (Qinhuangdao) Technology Co., Ltd. | 2026-04-06 |
| Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One (K260783) | Kulzer, LLC | 2026-03-11 |
Recalls involving this device
No recalls on record reference this clearance.