BA Pit & Fissure Sealant
FDA 510(k) K190998 · Apex Dental Materials, Inc.
510(k) numberK190998
Submission
- Device name
- BA Pit & Fissure Sealant
- Applicant
- Apex Dental Materials, Inc.
Lake Zurich, IL, US - Received
- April 16, 2019
- Decision date
- November 8, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code EBC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260819 | Any-Com SealEBC · Traditional | Mediclus Co., Ltd. | 05/01/2026SE |
| K243254 | Parkell Pit and Fissure SealantEBC · Abbreviated | Parkell, Inc. | 08/08/2025SE |
| K232498 | UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by NobioEBC · Traditional | Ultradent Product, Inc. | 08/18/2023SE |
| K230455 | Enamel Coating ResinEBC · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 07/25/2023SE |
| K190339 | Helioseal F PlusEBC · Abbreviated | Ivoclar Vivadent, AG | 07/29/2019SE |
| K172169 | Pulpdent (Activa) Pit and Fissure Sealant with MCPEBC · Traditional | Pulpdent Corporation | 01/05/2018SE |
| K171330 | Nanova SealantEBC · Traditional | Nanova Biomaterials, Inc. | 09/08/2017SE |
| K162598 | HAPI SealEBC · Traditional | Bisco, Inc. | 05/23/2017SE |
| K161580 | Premier SealantEBC · Traditional | Premier Dental Company Products | 10/18/2016SE |
| K141717 | Pacseal Pit & Fissure SealantEBC · Traditional | Pac-Dent International, Inc. | 03/09/2015SE |
More from Pac-Dent International, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K161077 | RnD TE and RnD SEKLE · Traditional | 03/17/2017SE |
| K131043 | Apex Universal AdhesiveKLE · Traditional | 09/10/2013SE |
| K131049 | ZRPKLE · Traditional | 08/27/2013SE |
| K120620 | Clean and BoostKLE · Traditional | 05/31/2012SE |
| K110859 | Metal OpaquerEBF · Traditional | 06/23/2011SE |
| K092539 | SeamfreeEBF · Traditional | 10/01/2009SE |
| K091647 | InjectafilEBF · Traditional | 09/21/2009SE |
| K062157 | ConformEBF · Traditional | 10/13/2006SE |
| K061981 | SurpassKLE · Abbreviated | 07/31/2006SE |
| K053103 | InterfaceKLE · Abbreviated | 02/01/2006SE |
Questions and answers
When was BA Pit & Fissure Sealant cleared by the FDA?
BA Pit & Fissure Sealant (K190998) received a 510(k) decision of Substantially Equivalent on November 8, 2019, 206 days after the submission was received.
What is the product code of K190998?
The FDA product code is EBC – Sealant, Pit And Fissure, And Conditioner, a Class II (moderate risk) device regulated under 21 CFR 872.3765.