Uninhibited
FDA 510(k) K021503 · Bisco, Inc.
510(k) numberK021503
Submission
- Device name
- Uninhibited
- Applicant
- Bisco, Inc.
Schaumburg, IL, US - Received
- May 9, 2002
- Decision date
- August 1, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K250156 | Choice 2 DCEMA · Traditional | 07/11/2025SE |
| K242816 | QuantiumEBF · Traditional | 12/17/2024SE |
| K192007 | TheraBase, TheraBase CaEMA · Traditional | 03/17/2020SE |
| K182917 | FluoroCalLBH · Traditional | 11/18/2019SE |
| K180344 | TheraCal DCEJK · Special | 04/05/2018SE |
| K171147 | REVEAL BulkEBF · Traditional | 08/04/2017SE |
| K162598 | HAPI SealEBC · Traditional | 05/23/2017SE |
| K163171 | CeraCleanPME · Traditional | 04/14/2017SE |
| K161051 | All-Bond Universal w/BAC (not finalized)KLE · Traditional | 09/09/2016SE |
| K161256 | TheraCemEMA · Traditional | 07/29/2016SE |
Questions and answers
When was Uninhibited cleared by the FDA?
Uninhibited (K021503) received a 510(k) decision of Substantially Equivalent on August 1, 2002, 84 days after the submission was received.
What is the product code of K021503?
The FDA product code is EBD – Coating, Filling Material, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3310.