EBC · Sealant, Pit And Fissure, And Conditioner
Dental · 21 CFR 872.3765 · Class 2
Overview
| Product Code | EBC |
|---|---|
| Device Name | Sealant, Pit And Fissure, And Conditioner |
| Regulation | 21 CFR 872.3765 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
Identification
A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 130)
Showing 20 most recent of 130 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243254 | Parkell Pit and Fissure Sealant | Parkell, Inc. | Aug 8, 2025 | SESE |
| K232498 | UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio | Ultradent Product, Inc. | Aug 18, 2023 | SESE |
| K230455 | Enamel Coating Resin | Rizhao Huge Biomaterials Company, Ltd. | Jul 25, 2023 | SESE |
| K190998 | BA Pit & Fissure Sealant | Apex Dental Materials, Inc. | Nov 8, 2019 | SESE |
| K190339 | Helioseal F Plus | Ivoclar Vivadent, AG | Jul 29, 2019 | SESE |
| K172169 | Pulpdent (Activa) Pit and Fissure Sealant with MCP | Pulpdent Corporation | Jan 5, 2018 | SESE |
| K171330 | Nanova Sealant | Nanova Biomaterials, Inc. | Sep 8, 2017 | SESE |
| K162598 | HAPI Seal | Bisco, Inc. | May 23, 2017 | SESE |
| K161580 | Premier Sealant | Premier Dental Company Products | Oct 18, 2016 | SESE |
| K141717 | PACSEAL PIT & FISSURE SEALANT | Pac-Dent International, Inc. | Mar 9, 2015 | SESE |
| K130485 | CONTROL SEAL | Voco GmbH | Feb 11, 2014 | SESE |
| K122521 | PREVENT SEAL | Itena Clinical | Jun 11, 2013 | SESE |
| K113818 | EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL | Pulpdent Corporation | Mar 21, 2012 | SESE |
| K112517 | ULTRASEAL XT HYDRO | Ultradent Products, Inc. | Sep 23, 2011 | SESE |
| K111782 | BEAUTISEALANT | Shofu Dental Corporation | Sep 16, 2011 | SESE |
| K110058 | BPA-FREE PIT AND FISSURE SEALANT | Novocol Inc. Dba Septodont and Confi-Dental Produc | Mar 31, 2011 | SESE |
| K102252 | DMP PIT & FISSURE SEALANT | Dmp, Ltd. | Dec 3, 2010 | SESE |
| K103121 | ECO-S | Vericom Co., Ltd. | Oct 26, 2010 | SESE |
| K101245 | ULTRASEAL ID | Ultradent Products, Inc. | Sep 17, 2010 | SESE |
| K100062 | INFILTRATION KIT | Dmg USA, Inc. | Mar 26, 2010 | SESE |
Top Applicants
- Dentsply Intl. — 11 clearances
- Ultradent Products, Inc. — 7 clearances
- Pulpdent Corp. — 6 clearances
- Voco GmbH — 5 clearances
- Confi-Dental Products Co. — 4 clearances
