Monarch II Bleaching Instrument
FDA 510(k) K854692 · Almore Intl., Inc.
510(k) numberK854692
Submission
- Device name
- Monarch II Bleaching Instrument
- Applicant
- Almore Intl., Inc.
Portland, OR, US - Received
- November 21, 1985
- Decision date
- May 12, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K122725 | Tanda Pearl, Ultrawyte, PearlEEG · Traditional | Syneron Beauty | 11/27/2012SE |
| K110888 | Absolute White LightEEG · Traditional | Dr. Fresh, Inc. | 01/12/2012SE |
| K063704 | Britewhite Teeth Whitening System, Model BW1101EEG · Traditional | Beks Incorporated | 02/20/2007SE |
| K052040 | QuicksmileEEG · Traditional | Cosmetic Dental Materials, Inc. | 10/18/2005SE |
| K042153 | South Beach Smile Light Whitening SystemEEG · Traditional | Dentovations, Inc. | 11/08/2004SE |
| K041392 | Sonx 35 Ultrasonic Bleaching System; Soniwhite Ultra Sonic, Model Quick White USEEG · Traditional | CAO Group, Inc. | 11/08/2004SE |
| K895174 | Union Broach Bleaching LightEEG · Traditional | Union Broach, Div. Moyco Industries, Inc. | 04/13/1990SE |
| K884937 | BEEHIVE-64 or BEEHIVE-32, Digital EEG RecordingEEG · Traditional | Grass-Telefactor Product Group | 04/14/1989SE |
| K862385 | Schein Bleaching UnitEEG · Traditional | Henry Schein, Inc. | 10/30/1986SE |
| K832179 | Hot Probe Model 6001EEG · Traditional | Analytic Technology | 10/04/1983SE |
More from Analytic Technology
| 510(k) | Device | Decision |
|---|---|---|
| K862851 | Almore Face Mask · Traditional | 08/12/1986SE |
| K854696 | Op II Visible Light Curing SystemEBZ · Traditional | 03/26/1986SE |
| 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 Monarch II Bleaching Instrument cleared by the FDA?
Monarch II Bleaching Instrument (K854692) received a 510(k) decision of Substantially Equivalent on May 12, 1986, 172 days after the submission was received.
What is the product code of K854692?
The FDA product code is EEG – Heat Source For Bleaching Teeth, a Class I (low risk) device regulated under 21 CFR 872.6475.