Pulpdent Cavity Preparation IV
FDA 510(k) K013411 · Pulpdent Corp.
510(k) numberK013411
Submission
- Device name
- Pulpdent Cavity Preparation IV
- Applicant
- Pulpdent Corp.
Watertown, MA, US - Received
- October 15, 2001
- Decision date
- December 12, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code LBH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262243 | Profisil FreeLBH · Traditional | Kettenbach GmbH & Co. KG | 09/03/2026SE |
| K253052 | Fluoride Varnish (Type A,Type C)LBH · Traditional | Nagy Oral Technology Qinhuangdao Co., Ltd. | 06/11/2026SE |
| K252073 | VOCO Profluorid Varnish + BioMinLBH · Traditional | Voco GmbH | 05/01/2026SE |
| K261404 | UltraEZLBH · Special | Ultradent Products, Inc. | 04/30/2026SE |
| K260830 | APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)LBH · Traditional | Sangi Co., Ltd. | 03/18/2026SE |
| K250714 | FluoroDose VarnishLBH · Traditional | Centrix, Inc. | 11/21/2025SE |
| K243777 | Rennou Varnish (3% / Spearmint); Rennou Varnish (3% / Strawberry); Rennou Varnish (3%…LBH · Traditional | Theodent, LLC | 05/27/2025SE |
| K241489 | ReminGelLBH · Traditional | Inter-Med, Inc. | 01/08/2025SE |
| K241568 | CrystLCare PRO Biorestorative, Fluoride-PlusLBH · Traditional | GreenMark Biomedical, Inc. | 01/02/2025SE |
| K242913 | Jasmate® ToothpasteLBH · Traditional | Jasberry Healthcare Private Limited | 11/22/2024SE |
More from Jasberry Healthcare Private Limited
| 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 Cavity Preparation IV cleared by the FDA?
Pulpdent Cavity Preparation IV (K013411) received a 510(k) decision of Substantially Equivalent on December 12, 2001, 58 days after the submission was received.
What is the product code of K013411?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.