Atlas FDA

EAZ

23 FDA 510(k) clearances · Product code

92 daysmedian time to decision
382 days90th percentile
23clearances measured

FDA profile

Official device name
Light, Operating, Dental
Device class
Class I (low risk)
Regulation
21 CFR 872.4630
Medical specialty
Dental
Adverse events (MAUDE)
2012: 21 · 2013: 18 · 2014: 13 · 2015: 13 · 2016: 9 · 2017: 11
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
MICROLUX/BLU (K072309)Addent, Inc.2007-11-19
MICROLUX DL (K041614)Addent, Inc.2005-04-04
VIZILITE-BLUE ORAL EXAM KIT (K033033)Trylon Corp.2004-11-22
SPECULITE/ORALLITE (K003995)Trylon Corp.2001-03-16
DENTAL LIGHT (K926081)Mdt Corp., Inc.1994-01-26
SIROLUX FANTASTIC (K935390)Pelton & Crane Co.1993-12-10
ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT (K925629)Den-Tal-Ez Mfg Co., Inc.1993-11-23
DELIGHT (K923462)Planmeca USA, Inc.1992-12-21
MICRONAIRE ISO-HOOD MAX 5UV (K912142)Micronaire Corp.1991-10-30
MINIFLEX AND PERSONAL UNIT (K912997)Dabi-Atlante America Corp.1991-10-30
DEFIANCE MODEL FUS 336 (K902685)Defiance Electronics, Inc.1990-09-17
ISOLIGHT (K894059)Eurodent, Inc.1989-09-07
A-DEC DENTAL LIGHT (K893044)A-Dec, Inc.1989-07-14
DENTAL EQUIPMENT PROTECTION DEVICES (K891216)Pro-Safe Professional Linens, Inc.1989-06-02
DENTAL LAMP HANDLE COVER (K884223)Steri-Shield Products, Inc.1989-03-17
THE WOOG ORATEST (K874374)Woog Intl.1988-01-19
F-11 REFLECTOR / F-II STANDARD REFLECTOR (K863019)Sds Dental, Inc.1986-09-29
OPTI-BEAM IV (K832919)Dentsply Intl.1984-03-02
LUNA-VUE DENTAL OPERATING LIGHT (K801683)Pacific Dental Corp.1980-08-04
KLIP-LITE (K790984)Innovators, Inc.1979-10-22
DENTAL LIGHT (K772351)Chemetron Dental Products1978-01-17
JOY LIGHT (K771249)M.D. Intl., Inc.1977-07-15
RITTER STARLIGHT DENTAL OPERATING LIGHT (K760707)Ritter Co.1976-10-05

Track EAZ automatically

Every clearance here is in the API, with alerts when new ones post.