Premier Self-Etching Enamel Sealant
FDA 510(k) K061997 · Premier Dental Products Co.
510(k) numberK061997
Submission
- Device name
- Premier Self-Etching Enamel Sealant
- Applicant
- Premier Dental Products Co.
Plymouth Meeting, PA, US - Received
- July 14, 2006
- Decision date
- October 4, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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|---|---|---|---|
| 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 |
|---|---|---|
| K260682 | Bond-PR Universal AdhesiveKLE · Traditional | 03/03/2026SE |
| K253513 | MultiMatch Flow Chameleon AntiMicrobial CompositeEBF · Traditional | 11/07/2025SE |
| K223632 | Premier's MultiMatch Universal Chameleon Restorative CompositeEBF · Traditional | 12/06/2022SE |
| K141839 | Premier EtchKLE · Traditional | 11/17/2014SE |
| K132526 | Knit-Pak+MVL · Traditional | 11/26/2013SE |
| K131212 | Premier Ceramic PrimerKLE · Traditional | 08/26/2013SE |
| K083695 | TraxodentMVL · Traditional | 04/28/2009SE |
| K062683 | Enamel Pro VarnishLBH · Traditional | 11/21/2006SE |
| K062166 | Enamel ProEJR · Traditional | 11/21/2006SE |
| K061998 | Premier Self-Etching Bond EnhancerKLE · Traditional | 10/04/2006SE |
Questions and answers
When was Premier Self-Etching Enamel Sealant cleared by the FDA?
Premier Self-Etching Enamel Sealant (K061997) received a 510(k) decision of Substantially Equivalent on October 4, 2006, 82 days after the submission was received.
What is the product code of K061997?
The FDA product code is EBC – Sealant, Pit And Fissure, And Conditioner, a Class II (moderate risk) device regulated under 21 CFR 872.3765.