Pulpdent (Activa) Pit and Fissure Sealant with MCP
FDA 510(k) K172169 · Pulpdent Corporation
510(k) numberK172169
Submission
- Device name
- Pulpdent (Activa) Pit and Fissure Sealant with MCP
- Applicant
- Pulpdent Corporation
Watertown, MA, US - Received
- July 18, 2017
- Decision date
- January 5, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K190339 | Helioseal F PlusEBC · Abbreviated | Ivoclar Vivadent, AG | 07/29/2019SE |
| 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 |
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| K173020 | OBA-MCP, Orthodontic Bracket Adhesive with MCPDYH · Traditional | 01/17/2018SE |
| K153249 | Pulpdent Solo Flowable Composite with MCPEBF · Traditional | 04/01/2016SE |
| K130223 | Rmgi FillEMA · Traditional | 03/29/2013SE |
| K123265 | Rmgi Low ViscosityEMA · Traditional | 12/07/2012SE |
| K120784 | Tuff-Temp 2.0EBG · Traditional | 06/08/2012SE |
| K120003 | NucalEJK · Traditional | 04/05/2012SE |
| K120213 | Etch-Rite SupremeKLE · Traditional | 03/30/2012SE |
| K113818 | Embrace Wetbond Pit and Fissure Sealant, Low FillEBC · Traditional | 03/21/2012SE |
| K113711 | Lime-Lite IIEJK · Traditional | 03/05/2012SE |
Questions and answers
When was Pulpdent (Activa) Pit and Fissure Sealant with MCP cleared by the FDA?
Pulpdent (Activa) Pit and Fissure Sealant with MCP (K172169) received a 510(k) decision of Substantially Equivalent on January 5, 2018, 171 days after the submission was received.
What is the product code of K172169?
The FDA product code is EBC – Sealant, Pit And Fissure, And Conditioner, a Class II (moderate risk) device regulated under 21 CFR 872.3765.