Op II Visible Light Curing System
FDA 510(k) K854696 · Almore Intl., Inc.
510(k) numberK854696
Submission
- Device name
- Op II Visible Light Curing System
- Applicant
- Almore Intl., Inc.
Portland, OR, US - Received
- November 21, 1985
- Decision date
- March 26, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K253131 | Curing Light (M-Cure 6)EBZ · Traditional | Guangzhou Rebornendo Medical Instrument Co., Ltd. | 06/18/2026SE |
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| K241238 | LOOP LED Curing Light System (CLK01)EBZ · Traditional | Garrison Dental Solutions, LLC | 08/01/2024SE |
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| K223142 | Coltolux Comfort LED Curing LightEBZ · Traditional | Dent4you AG | 12/22/2022SE |
More from Dent4you AG
| 510(k) | Device | Decision |
|---|---|---|
| K862851 | Almore Face Mask · Traditional | 08/12/1986SE |
| K854692 | Monarch II Bleaching InstrumentEEG · Traditional | 05/12/1986SE |
| K854691 | Diamond Burs-HandpieceEJL · Traditional | 03/25/1986SE |
| K854690 | Diamonds Burs-Composit FinishingEJL · Traditional | 03/25/1986SE |
| K854700 | Ez-On Tubing Conditioner (Lubricant) · Traditional | 03/12/1986SE |
| K854702 | Plastic Mounting RingsEJP · Traditional | 03/06/1986SE |
| K854701 | Retract-A-CordJES · Traditional | 03/06/1986SE |
| K854697 | Tubing Handpiece ReplacementEFB · Traditional | 03/06/1986SE |
| K854699 | Tubing SyringECB · Traditional | 01/06/1986SE |
| K831136 | Double Bow Tooth SeparatorJEP · Traditional | 06/08/1983SE |
Questions and answers
When was Op II Visible Light Curing System cleared by the FDA?
Op II Visible Light Curing System (K854696) received a 510(k) decision of Substantially Equivalent on March 26, 1986, 125 days after the submission was received.
What is the product code of K854696?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.