Medental Chemical Curing Sealant Pit & Fissure Tinted
FDA 510(k) K973541 · Medental Intl.
510(k) numberK973541
Submission
- Device name
- Medental Chemical Curing Sealant Pit & Fissure Tinted
- Applicant
- Medental Intl.
Evergreen, CO, US - Received
- September 18, 1997
- Decision date
- November 25, 1997
- 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 |
|---|---|---|
| K990314 | Multi-Cure Composite CementEBF · Traditional | 04/02/1999SE |
| K983018 | Zinc Phosphate CementEMA · Traditional | 10/22/1998SE |
| K982779 | Medental Glass Ionomer Cement Type I and Mirage Glass Ionomer Cement Type 1EMA · Traditional | 09/30/1998SE |
| K982191 | Chemical Cure Composite with Enamel BondEBF · Traditional | 09/14/1998SE |
| K980990 | Polycarboxylate CementEMA · Traditional | 07/31/1998SE |
| K973919 | Cavity Varnish (Intermediary Varnish and Dentinal Tubuli Seal)LBH · Traditional | 12/16/1997SE |
Questions and answers
When was Medental Chemical Curing Sealant Pit & Fissure Tinted cleared by the FDA?
Medental Chemical Curing Sealant Pit & Fissure Tinted (K973541) received a 510(k) decision of Substantially Equivalent on November 25, 1997, 68 days after the submission was received.
What is the product code of K973541?
The FDA product code is EBC – Sealant, Pit And Fissure, And Conditioner, a Class II (moderate risk) device regulated under 21 CFR 872.3765.