Any-Com Seal
FDA 510(k) K260819 · Mediclus Co., Ltd.
510(k) numberK260819
Submission
- Device name
- Any-Com Seal
- Applicant
- Mediclus Co., Ltd.
Cheongju-Si, KR - Received
- March 13, 2026
- Decision date
- May 1, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code EBC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K190998 | BA Pit & Fissure SealantEBC · Abbreviated | Apex Dental Materials, Inc. | 11/08/2019SE |
| 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 |
|---|---|---|
| K262074 | Any-ZircosEIH · Traditional | 08/21/2026SE |
| K254201 | Any-CemEMA · Traditional | 08/13/2026SE |
| K261728 | One-Fil LCEJK · Traditional | 07/21/2026SE |
| K260485 | Any-EtchKLE · Traditional | 05/14/2026SE |
| K253797 | One-StopMVL · Traditional | 02/27/2026SE |
| K253167 | Any-PasteKIF · Traditional | 01/12/2026SE |
| K252465 | Any-CoreEBF · Traditional | 12/05/2025SE |
| K251884 | One-Fil Putty InjectableKIF · Special | 08/22/2025SE |
| K251283 | Once-Fil FlowEBF · Traditional | 06/06/2025SE |
| K250823 | Any-Com FlowEBF · Special | 04/14/2025SE |
Questions and answers
When was Any-Com Seal cleared by the FDA?
Any-Com Seal (K260819) received a 510(k) decision of Substantially Equivalent on May 1, 2026, 49 days after the submission was received.
What is the product code of K260819?
The FDA product code is EBC – Sealant, Pit And Fissure, And Conditioner, a Class II (moderate risk) device regulated under 21 CFR 872.3765.