No-Stick Composite Instrument Dip
FDA 510(k) K901050 · Pulpdent Corp.
510(k) numberK901050
Submission
- Device name
- No-Stick Composite Instrument Dip
- Applicant
- Pulpdent Corp.
Watertown, MA, US - Received
- March 5, 1990
- Decision date
- April 19, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EBD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254091 | Glossy Coat (15ML)EBD · Traditional | YAMAHACHI DENTAL MFG., Co. | 04/06/2026SE |
| K250804 | Id Light Cure SystemEBD · Traditional | Id Korea Co., Ltd. | 06/04/2025SE |
| K240735 | visio.lign color, visio.lign shieldEBD · Traditional | Bredent GmbH & Co. KG | 12/12/2024SE |
| K223365 | RODIN Palette Naturalizing KitEBD · Traditional | Belport Company, Inc., Gingi-Pak | 03/27/2023SE |
| K211854 | VITA Akzent LCEBD · Traditional | Vita Zahnfabrik GmbH H Rauter & CO | 11/22/2021SE |
| K162408 | Nano Varnish, Plaquit, Lightpaint on SurfaceEBD · Traditional | Dreve Dentamid GmbH | 04/05/2018SE |
| K163568 | Shofu Resin GlazeEBD · Traditional | Shofu Dental Corporation | 08/16/2017SE |
| K133836 | Optiglaze ColorEBD · Traditional | GC America, Inc. | 03/06/2014SE |
| K123761 | Vita Enamic StainsEBD · Traditional | Innovation Meditech GmbH | 03/01/2013SE |
| K093019 | Enamelite Acryseal Spray SealantEBD · Traditional | Enamelite, LLC | 12/22/2009SE |
More from Enamelite, LLC
| 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 No-Stick Composite Instrument Dip cleared by the FDA?
No-Stick Composite Instrument Dip (K901050) received a 510(k) decision of Substantially Equivalent on April 19, 1990, 45 days after the submission was received.
What is the product code of K901050?
The FDA product code is EBD – Coating, Filling Material, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3310.