510(k) K243254
- Device
- Parkell Pit and Fissure Sealant
- Applicant
- Parkell, Inc.
- 510(k) number
- K243254
- Product code
- EBC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-08-08
- Date received
- 2024-10-15
- Regulation
- 872.3765
- Classification name
- Sealant, Pit And Fissure, And Conditioner
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- David Mott
- Address
- 300 Executive Dr. Edgewood NJ US 11717 11717
FDA Registration Numbers
- 3002789526
- 3005176727
- 1410097
- 3013584861
- 9612352
- 3006316962
- 1281412
- 3017674095
- 1420052
- 3031841433
- 9681356
- 2241860
- 2086043
- 3013557697
- 3006694515
- 3012187973
- 1424442
- 3005665377
- 9613953
- 3003449480
- 3008912871
- 1215305
- 3010131268
- 3011689956
- 3004967419
- 8010908
- 2511556
- 1000118628
- 3012627824
- 2424472
- 2024980
- 3038718579
- 9681210
- 1000272892
- 3010002722
- 3008966075
- 1721647
- 3006444232
- 2515379
- 3025307990
- 3043226252
- 3013410675
- 8020994
- 9612300
- 1723973
- 1413475
- 3018047916
- 3042244574
- 8044164
- 3007210751
- 3002808149
- 2183301
- 3042272797
- 2133714
- 3012494290
- 1718912
- 9681254
- 3000219976
- 2921595
- 3014615644
- 3009496224
- 2244842
- 3010664129
- 9680845
- 2022039
- 3011430871
- 9610902
- 3032163716
- 3006367836
- 3006805063
- 3016447764
- 1013257
- 3004966444
- 2437780
- 3012996495
- 3012477813
- 3012421607
- 1450653
- 3018507299
Source Documents
Other 510(k) Records For Product Code EBC
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260819 | Any-Com Seal | Mediclus Co., Ltd. | 2026-05-01 |
| K232498 | UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio | Ultradent Product, Inc. | 2023-08-18 |
| K230455 | Enamel Coating Resin | Rizhao Huge Biomaterials Company, Ltd. | 2023-07-25 |
| K190998 | BA Pit & Fissure Sealant | Apex Dental Materials, Inc. | 2019-11-08 |
| K190339 | Helioseal F Plus | Ivoclar Vivadent, AG | 2019-07-29 |
| K172169 | Pulpdent (Activa) Pit and Fissure Sealant with MCP | Pulpdent Corporation | 2018-01-05 |
| K171330 | Nanova Sealant | Nanova Biomaterials, Inc. | 2017-09-08 |
| K162598 | HAPI Seal | Bisco, Inc. | 2017-05-23 |
| K161580 | Premier Sealant | Premier Dental Company Products | 2016-10-18 |
| K141717 | PACSEAL PIT & FISSURE SEALANT | Pac-Dent International, Inc. | 2015-03-09 |
| K130485 | CONTROL SEAL | Voco GmbH | 2014-02-11 |
| K122521 | PREVENT SEAL | Itena Clinical | 2013-06-11 |
| K113818 | EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL | Pulpdent Corporation | 2012-03-21 |
| K112517 | ULTRASEAL XT HYDRO | Ultradent Products, Inc. | 2011-09-23 |
| K111782 | BEAUTISEALANT | Shofu Dental Corporation | 2011-09-16 |