Resilience M5 Protection Plus
FDA 510(k) K955329 · Confi-Dental Products Co.
510(k) numberK955329
Submission
- Device name
- Resilience M5 Protection Plus
- Applicant
- Confi-Dental Products Co.
Louisville, CO, US - Received
- November 20, 1995
- Decision date
- March 28, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K952930 | Dentray II Plus Tray AdhesiveELW · Traditional | 09/08/1995SE |
| K946307 | Cyrstalline L3 Multi-Use Hybrid CompositeEBF · Traditional | 01/26/1995SE |
| K940546 | Granitec Ionomer Resin CementEMA · Traditional | 04/29/1994SE |
| K936070 | Trend Set 2 PlusELW · Traditional | 02/04/1994SE |
| K935714 | Crystalline L3 Multi-Use Hybrid CompositeDYH · Traditional | 01/21/1994SE |
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Questions and answers
When was Resilience M5 Protection Plus cleared by the FDA?
Resilience M5 Protection Plus (K955329) received a 510(k) decision of Substantially Equivalent on March 28, 1996, 129 days after the submission was received.
What is the product code of K955329?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.