Chemical Cure Composite with Enamel Bond
FDA 510(k) K982191 · Medental Intl.
510(k) numberK982191
Submission
- Device name
- Chemical Cure Composite with Enamel Bond
- Applicant
- Medental Intl.
Evergreen, CO, US - Received
- June 22, 1998
- Decision date
- September 14, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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|---|---|---|
| K990314 | Multi-Cure Composite CementEBF · Traditional | 04/02/1999SE |
| K983018 | Zinc Phosphate CementEMA · Traditional | 10/22/1998SE |
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| K980990 | Polycarboxylate CementEMA · Traditional | 07/31/1998SE |
| K973919 | Cavity Varnish (Intermediary Varnish and Dentinal Tubuli Seal)LBH · Traditional | 12/16/1997SE |
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Questions and answers
When was Chemical Cure Composite with Enamel Bond cleared by the FDA?
Chemical Cure Composite with Enamel Bond (K982191) received a 510(k) decision of Substantially Equivalent on September 14, 1998, 84 days after the submission was received.
What is the product code of K982191?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.