Burr, Dental
FDA 510(k) K801886 · Aesculap Instruments Corp.
510(k) numberK801886
Submission
- Device name
- Burr, Dental
- Applicant
- Aesculap Instruments Corp.
Mchenry, IL, US - Received
- July 28, 1980
- Decision date
- August 20, 1980
- 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 |
|---|---|---|
| K890182 | Protegraft DV 1500, 1900 & Low Por, Unigraft DVDSY · Traditional | 02/28/1990SE |
| K885046 | Insitucat Valve StripperDWQ · Traditional | 02/28/1990SE |
| K890443 | Caspar Scalp Clip, ApplierHBO · Traditional | 06/15/1989SE |
| K893121 | Robotrac (TM) Retractor ArmGAD · Traditional | 06/01/1989SE |
| K884057 | Elan-E Disposable DrapeKKX · Traditional | 10/19/1988SE |
| K880704 | Cerullo Suction RegulatorGCX · Traditional | 03/29/1988SE |
| K860016 | Aesculap Bone MillLYS · Traditional | 03/19/1986SE |
| K801888 | Handpiece, DentalDZA · Traditional | 08/20/1980SE |
| K801887 | Drill, DentalDZA · Traditional | 08/20/1980SE |
| K792558 | Container SystemFLE · Traditional | 12/27/1979SE |
Questions and answers
When was Burr, Dental cleared by the FDA?
Burr, Dental (K801886) received a 510(k) decision of Substantially Equivalent on August 20, 1980, 23 days after the submission was received.
What is the product code of K801886?
The FDA product code is EJL – Bur, Dental, a Class I (low risk) device regulated under 21 CFR 872.3240.