Jeldent Multicryl
FDA 510(k) K990056 · J.F. Jelenko & Co., Inc.
510(k) numberK990056
Submission
- Device name
- Jeldent Multicryl
- Applicant
- J.F. Jelenko & Co., Inc.
Armonk, NY, US - Received
- January 7, 1999
- Decision date
- March 25, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K000532 | Jel 15EJS · Traditional | 04/06/2000SE |
| K000213 | Jeldent Basic LineELM · Traditional | 04/06/2000SE |
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Questions and answers
When was Jeldent Multicryl cleared by the FDA?
Jeldent Multicryl (K990056) received a 510(k) decision of Substantially Equivalent on March 25, 1999, 77 days after the submission was received.
What is the product code of K990056?
The FDA product code is EBI – Resin, Denture, Relining, Repairing, Rebasing, a Class II (moderate risk) device regulated under 21 CFR 872.3760.