Pulpdent Snoop
FDA 510(k) K964430 · Pulpdent Corp.
510(k) numberK964430
Submission
- Device name
- Pulpdent Snoop
- Applicant
- Pulpdent Corp.
Watertown, MA, US - Received
- November 5, 1996
- Decision date
- January 17, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code LFC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K222560 | BlueCheck Caries Detection & MonitoringLFC · Traditional | Incisive Technologies Pty, Ltd. | 05/16/2023SE |
| K200601 | LumiCare Caries Diagnostic RinseLFC · Traditional | GreenMark Biomedical, Inc. | 03/29/2021SE |
| K193447 | Vista DyesLFC · Traditional | Inter-Med/Vista Dental Products | 03/11/2020SE |
| K102821 | DiscovredLFC · Traditional | Phoenix Dental, Inc. | 03/11/2011SE |
| K060330 | See-It Caries DetectorLFC · Traditional | Ronvig Dental Mfg. A/S | 04/07/2006SE |
| K030807 | Caries IndicatorLFC · Traditional | Confi-Dental Products Co. | 06/09/2003SE |
| K012733 | Caries DetectorLFC · Traditional | Kuraray Medical, Inc. | 09/14/2001SE |
| K994368 | American Dental Products Caries-Detector PlusLFC · Traditional | American Dental Products, Inc. | 03/14/2000SE |
| K982105 | Oral Potential Meter (Opm)LFC · Traditional | Pertec of Wisconsin, Inc. | 09/16/1998SE |
| K973200 | Caries StainLFC · Traditional | Parkell, Inc. | 11/06/1997SE |
More from Parkell, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K210045 | Activa Presto PackEBF · Traditional | 09/22/2021SE |
| K173020 | OBA-MCP, Orthodontic Bracket Adhesive with MCPDYH · Traditional | 01/17/2018SE |
| K172169 | Pulpdent (Activa) Pit and Fissure Sealant with MCPEBC · Traditional | 01/05/2018SE |
| 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 |
Questions and answers
When was Pulpdent Snoop cleared by the FDA?
Pulpdent Snoop (K964430) received a 510(k) decision of Substantially Equivalent on January 17, 1997, 73 days after the submission was received.
What is the product code of K964430?
The FDA product code is LFC – Device, Caries Detection, a Class II (moderate risk) device regulated under 21 CFR 872.1740.