Silicont Bur Block
FDA 510(k) K921406 · Innovators, Inc.
510(k) numberK921406
Submission
- Device name
- Silicont Bur Block
- Applicant
- Innovators, Inc.
Jefferson City, MO, US - Received
- March 20, 1992
- Decision date
- April 28, 1992
- 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 |
| K926205 | MonosterylEJL · Traditional | Utensili Super Abrasivi | 02/10/1994SE |
| K923883 | Dental or Surgical BurEJL · Traditional | Stratum Dental Technologies, Inc. | 07/27/1993SE |
| 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 |
More from Tri-Stage, Inc.
Questions and answers
When was Silicont Bur Block cleared by the FDA?
Silicont Bur Block (K921406) received a 510(k) decision of Substantially Equivalent on April 28, 1992, 39 days after the submission was received.
What is the product code of K921406?
The FDA product code is EJL – Bur, Dental, a Class I (low risk) device regulated under 21 CFR 872.3240.