Diamond Burs-Handpiece
FDA 510(k) K854691 · Almore Intl., Inc.
510(k) numberK854691
Submission
- Device name
- Diamond Burs-Handpiece
- Applicant
- Almore Intl., Inc.
Portland, OR, US - Received
- November 21, 1985
- Decision date
- March 25, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EJL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K080687 | SmartbursEJL · Traditional | S.S. White Burs, Inc. | 06/20/2008SE |
| K071352 | CeradrillEJL · Traditional | Gebr. Brasseler GmbH & Co. KG | 06/29/2007SE |
| K061383 | Bti Sterile Dental Drills Kit, Bti Abutments and CapsEJL · Traditional | B.T.I. Biotechnology Institute, Sl. | 08/03/2006SE |
| K943273 | Tri Hawk Bur, FG BurEJL · Traditional | Tri Hawk Corp. | 08/01/1994SE |
| K926205 | MonosterylEJL · Traditional | Utensili Super Abrasivi | 02/10/1994SE |
| K923883 | Dental or Surgical BurEJL · Traditional | Stratum Dental Technologies, Inc. | 07/27/1993SE |
| K921406 | Silicont Bur BlockEJL · Traditional | Innovators, Inc. | 04/28/1992SE |
| K920243 | Smart Burs Total CarbidesEJL · Traditional | Vermont Diamond Instruments | 03/25/1992SE |
| K911208 | Tin Coated Dental BursEJL · Traditional | Surgical Precision Instruments, Corp. | 09/16/1991SE |
| K910794 | Small Instrument Sterilization/Bur BoxEJL · Traditional | Brevet, Inc. | 05/23/1991SE |
More from Brevet, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K862851 | Almore Face Mask · Traditional | 08/12/1986SE |
| K854692 | Monarch II Bleaching InstrumentEEG · Traditional | 05/12/1986SE |
| K854696 | Op II Visible Light Curing SystemEBZ · Traditional | 03/26/1986SE |
| 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 Diamond Burs-Handpiece cleared by the FDA?
Diamond Burs-Handpiece (K854691) received a 510(k) decision of Substantially Equivalent on March 25, 1986, 124 days after the submission was received.
What is the product code of K854691?
The FDA product code is EJL – Bur, Dental, a Class I (low risk) device regulated under 21 CFR 872.3240.