Ortho Light Cure
FDA 510(k) K913854 · Ortho Source
510(k) numberK913854
Submission
- Device name
- Ortho Light Cure
- Applicant
- Ortho Source
North Hollywood, CA, US - Received
- August 27, 1991
- Decision date
- January 14, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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More from Dentscare Ltda
| 510(k) | Device | Decision |
|---|---|---|
| K913853 | Fissure SealerEBC · Traditional | 08/27/1992SE |
| K913519 | Sumo Glass Ionomer CementEMA · Traditional | 11/19/1991SE |
| K884949 | Visible Light Cure Calcium Hydroxide LinerEJK · Traditional | 02/23/1989SE |
| K884575 | MaxibondDYH · Traditional | 01/03/1989SE |
| K861118 | Orthojoin, Orthodontic AdhesiveDYH · Traditional | 05/02/1986SE |
| K861258 | Permaband (Orthodontic Adhesive)DYH · Traditional | 04/17/1986SE |
| K861245 | Orthosource Etch SystemsEBC · Traditional | 04/11/1986SE |
| K860959 | DependabondDYH · Traditional | 03/25/1986SE |
Questions and answers
When was Ortho Light Cure cleared by the FDA?
Ortho Light Cure (K913854) received a 510(k) decision of Substantially Equivalent on January 14, 1992, 140 days after the submission was received.
What is the product code of K913854?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.