Wilde Adhesive Bonding System
FDA 510(k) K913581 · Wilde-USA, Inc.
510(k) numberK913581
Submission
- Device name
- Wilde Adhesive Bonding System
- Applicant
- Wilde-USA, Inc.
Chicago, IL, US - Received
- August 12, 1991
- Decision date
- February 26, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| 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 Wilde Adhesive Bonding System cleared by the FDA?
Wilde Adhesive Bonding System (K913581) received a 510(k) decision of Substantially Equivalent on February 26, 1993, 564 days after the submission was received.
What is the product code of K913581?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.