Core-Ide
FDA 510(k) K984037 · Roydent Dental Products, Inc.
510(k) numberK984037
Submission
- Device name
- Core-Ide
- Applicant
- Roydent Dental Products, Inc.
Rochester Hills, MI, US - Received
- November 12, 1998
- Decision date
- February 4, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 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 |
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Questions and answers
When was Core-Ide cleared by the FDA?
Core-Ide (K984037) received a 510(k) decision of Substantially Equivalent on February 4, 1999, 84 days after the submission was received.
What is the product code of K984037?
The FDA product code is EBD – Coating, Filling Material, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3310.