Fissure Sealer
FDA 510(k) K913853 · Ortho Source
510(k) numberK913853
Submission
- Device name
- Fissure Sealer
- Applicant
- Ortho Source
North Hollywood, CA, US - Received
- August 27, 1991
- Decision date
- August 27, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
More from Premier Dental Company Products
| 510(k) | Device | Decision |
|---|---|---|
| K913854 | Ortho Light CureDYH · Traditional | 01/14/1992SE |
| K913519 | Sumo Glass Ionomer CementEMA · Traditional | 11/19/1991SE |
| K884949 | Visible Light Cure Calcium Hydroxide LinerEJK · Traditional | 02/23/1989SE |
| K884575 | MaxibondDYH · Traditional | 01/03/1989SE |
| K861118 | Orthojoin, Orthodontic AdhesiveDYH · Traditional | 05/02/1986SE |
| K861258 | Permaband (Orthodontic Adhesive)DYH · Traditional | 04/17/1986SE |
| K861245 | Orthosource Etch SystemsEBC · Traditional | 04/11/1986SE |
| K860959 | DependabondDYH · Traditional | 03/25/1986SE |
Questions and answers
When was Fissure Sealer cleared by the FDA?
Fissure Sealer (K913853) received a 510(k) decision of Substantially Equivalent on August 27, 1992, 366 days after the submission was received.
What is the product code of K913853?
The FDA product code is EBC – Sealant, Pit And Fissure, And Conditioner, a Class II (moderate risk) device regulated under 21 CFR 872.3765.