Polycarboxylate Cement
FDA 510(k) K980990 · Medental Intl.
510(k) numberK980990
Submission
- Device name
- Polycarboxylate Cement
- Applicant
- Medental Intl.
Evergreen, CO, US - Received
- March 17, 1998
- Decision date
- July 31, 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 |
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| K982191 | Chemical Cure Composite with Enamel BondEBF · Traditional | 09/14/1998SE |
| K973919 | Cavity Varnish (Intermediary Varnish and Dentinal Tubuli Seal)LBH · Traditional | 12/16/1997SE |
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Questions and answers
When was Polycarboxylate Cement cleared by the FDA?
Polycarboxylate Cement (K980990) received a 510(k) decision of Substantially Equivalent on July 31, 1998, 136 days after the submission was received.
What is the product code of K980990?
The FDA product code is EMA – Cement, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.3275.