EJL
27 FDA 510(k) clearances · Product code
39 daysmedian time to decision
312 days90th percentile
27clearances measured
FDA profile
- Official device name
- Bur, Dental
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.3240
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 2019: 17 · 2021: 21 · 2022: 19 · 2024: 25 · 2025: 56 · 2026: 23
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SMARTBURS (K080687) | S.S. White Burs, Inc. | 2008-06-20 |
| CERADRILL (K071352) | Gebr. Brasseler GmbH & Co. KG | 2007-06-29 |
| BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS (K061383) | B.T.I. Biotechnology Institute, Sl. | 2006-08-03 |
| TRI HAWK BUR, FG BUR (K943273) | Tri Hawk Corp. | 1994-08-01 |
| MONOSTERYL (K926205) | Utensili Super Abrasivi | 1994-02-10 |
| DENTAL OR SURGICAL BUR (K923883) | Stratum Dental Technologies, Inc. | 1993-07-27 |
| SILICONT BUR BLOCK (K921406) | Innovators, Inc. | 1992-04-28 |
| SMART BURS TOTAL CARBIDES (K920243) | Vermont Diamond Instruments | 1992-03-25 |
| TIN COATED DENTAL BURS (K911208) | Surgical Precision Instruments, Corp. | 1991-09-16 |
| SMALL INSTRUMENT STERILIZATION/BUR BOX (K910794) | Brevet, Inc. | 1991-05-23 |
| DENTAL BURS (K882183) | Tri-Stage, Inc. | 1988-06-21 |
| STERILIZED DENTAL BIT PACKAGING (K873698) | Florida Diamond Instruments Corp. | 1987-12-03 |
| CB BUR (K863097) | Beavers Dental, Div. Sybron Canada, Ltd. | 1986-08-26 |
| DIAMONDS BURS-COMPOSIT FINISHING (K854690) | Almore Intl., Inc. | 1986-03-25 |
| DIAMOND BURS-HANDPIECE (K854691) | Almore Intl., Inc. | 1986-03-25 |
| BUR, DENTAL GUTTA PERCHA-FILE-PULP CANAL (K842720) | Penn-Med Technology, Inc. | 1985-05-21 |
| LEBLOND DIAMOND DENTAL BUR (K833598) | A & M Instruments, Inc. | 1983-12-29 |
| DENTAL INSTRUMENTS (K823314) | Miltex, Inc. | 1982-11-24 |
| JOTA TUNGSTEN CARBIDE & STEEL DENT. BURS (K802988) | Swiss American Metal Craft Corp. | 1980-12-30 |
| MEISINGER TUNGSTEN CARBIDE & STEEL DT.B. (K802989) | Swiss American Metal Craft Corp. | 1980-12-30 |
| BURR, DENTAL (K801886) | Aesculap Instruments Corp. | 1980-08-20 |
| DENTAL ROTARY CARBIDE BURS 76EJL (K780641) | Teledyne Densco | 1978-04-21 |
| R&R ALSTON CARBIDE BURS (K771347) | Ransom and Randolph | 1977-08-03 |
| SUPERFINE DIAMONDS (K771214) | Den-Mat Corp. | 1977-07-15 |
| CUTTER TUNGSTEN CARBIDE BURS (K770469) | Cutter Laboratories, Inc. | 1977-03-16 |
| DENTAL BURS (K770093) | The S. S. White Co. | 1977-01-24 |
| CARBIDE DENTAL BURS (K760986) | Adp Intl., Inc. | 1976-11-15 |
Track EJL automatically
Every clearance here is in the API, with alerts when new ones post.