CONTROL SEAL
FDA 510(k) clearance K130485 · decided 2014-02-11
Clearance details
- K-number
- K130485
- Device name
- CONTROL SEAL
- Applicant
- Voco GmbH
- Decision
- Substantially Equivalent
- Date received
- 2013-02-25
- Decision date
- 2014-02-11
- Days to decision
- 351 days
- Clearance type
- Traditional
- Product code
- EBC
- Device class
- 2
- Regulation number
- 872.3765
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Cuxhaven, DE
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Voco GmbH
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Any-Com Seal (K260819) | Mediclus Co., Ltd. | 2026-05-01 |
| Parkell Pit and Fissure Sealant (K243254) | Parkell, Inc. | 2025-08-08 |
| UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio (K232498) | Ultradent Product, Inc. | 2023-08-18 |
| Enamel Coating Resin (K230455) | Rizhao Huge Biomaterials Company, Ltd. | 2023-07-25 |
| BA Pit & Fissure Sealant (K190998) | Apex Dental Materials, Inc. | 2019-11-08 |
| Helioseal F Plus (K190339) | Ivoclar Vivadent, AG | 2019-07-29 |
| Pulpdent (Activa) Pit and Fissure Sealant with MCP (K172169) | Pulpdent Corporation | 2018-01-05 |
| Nanova Sealant (K171330) | Nanova Biomaterials, Inc. | 2017-09-08 |
| HAPI Seal (K162598) | Bisco, Inc. | 2017-05-23 |
| Premier Sealant (K161580) | Premier Dental Company Products | 2016-10-18 |
| PACSEAL PIT & FISSURE SEALANT (K141717) | Pac-Dent International, Inc. | 2015-03-09 |
| PREVENT SEAL (K122521) | Itena Clinical | 2013-06-11 |
Recalls involving this device
No recalls on record reference this clearance.