Hard Reliner
FDA 510(k) K011277 · S & C Polymer GmbH
510(k) numberK011277
Submission
- Device name
- Hard Reliner
- Applicant
- S & C Polymer GmbH
Elmshorn, DE - Received
- April 26, 2001
- Decision date
- June 26, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K031420 | S & C -Bracket AdhesivesDYH · Traditional | 08/20/2003SE |
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| K011431 | Resin CemEMA · Traditional | 06/11/2001SE |
| K011064 | Classic CemEMA · Traditional | 05/17/2001SE |
Questions and answers
When was Hard Reliner cleared by the FDA?
Hard Reliner (K011277) received a 510(k) decision of Substantially Equivalent on June 26, 2001, 61 days after the submission was received.
What is the product code of K011277?
The FDA product code is EBI – Resin, Denture, Relining, Repairing, Rebasing, a Class II (moderate risk) device regulated under 21 CFR 872.3760.