Monosteryl
FDA 510(k) K926205 · Utensili Super Abrasivi
510(k) numberK926205
Submission
- Device name
- Monosteryl
- Applicant
- Utensili Super Abrasivi
(Milan), Italy, IT - Received
- December 9, 1992
- Decision date
- February 10, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K882183 | Dental BursEJL · Traditional | Tri-Stage, Inc. | 06/21/1988SE |
Questions and answers
When was Monosteryl cleared by the FDA?
Monosteryl (K926205) received a 510(k) decision of Substantially Equivalent on February 10, 1994, 428 days after the submission was received.
What is the product code of K926205?
The FDA product code is EJL – Bur, Dental, a Class I (low risk) device regulated under 21 CFR 872.3240.