Parkell Pit and Fissure Sealant
FDA 510(k) clearance K243254 · decided 2025-08-08
Clearance details
- K-number
- K243254
- Device name
- Parkell Pit and Fissure Sealant
- Applicant
- Parkell, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-10-15
- Decision date
- 2025-08-08
- Days to decision
- 297 days
- Clearance type
- Abbreviated
- Product code
- EBC
- Device class
- 2
- Regulation number
- 872.3765
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Edgewood, NJ, US
- 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 |
|---|---|---|
| Any-Com Seal (K260819) | Mediclus Co., Ltd. | 2026-05-01 |
| 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 |
| CONTROL SEAL (K130485) | Voco GmbH | 2014-02-11 |
| PREVENT SEAL (K122521) | Itena Clinical | 2013-06-11 |
Recalls involving this device
No recalls on record reference this clearance.