Keramail
FDA 510(k) K915653 · Wilde-USA, Inc.
510(k) numberK915653
Submission
- Device name
- Keramail
- Applicant
- Wilde-USA, Inc.
Chicago, IL, US - Received
- December 18, 1991
- Decision date
- April 8, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K923472 | CompacolorEBF · Traditional | 10/13/1992SE |
| K920649 | CompasepFMC · Traditional | 07/23/1992SE |
| K915250 | Wil-Pds & Wil-Pdi Casting AlloysEJH · Traditional | 04/21/1992SE |
| K913089 | Wilde Light Curing Composite Restorative ResinsEBF · Traditional | 04/21/1992SE |
| K912990 | ConverbaseEBI · Traditional | 03/25/1992SE |
| K920557 | Wil-O-Dont Orthodontic Material/Wil-O-LuxEBI · Traditional | 03/20/1992SE |
| K915654 | Keralloy-D CapsEJJ · Traditional | 03/02/1992SE |
| K912993 | Wilde Denture ResinsEBI · Traditional | 02/03/1992SE |
Questions and answers
When was Keramail cleared by the FDA?
Keramail (K915653) received a 510(k) decision of Substantially Equivalent on April 8, 1993, 477 days after the submission was received.
What is the product code of K915653?
The FDA product code is EIH – Powder, Porcelain, a Class II (moderate risk) device regulated under 21 CFR 872.6660.