Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EAZ — Predicate Candidate Screening
23 FDA 510(k) clearances under this product code; the 50 most recent screened below.
92 daysmedian FDA review time
382 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K072309 | MICROLUX/BLU | Addent, Inc. | 2007-11-19 | 94 | 0 |
| K041614 | MICROLUX DL | Addent, Inc. | 2005-04-04 | 293 | 0 |
| K033033 | VIZILITE-BLUE ORAL EXAM KIT | Trylon Corp. | 2004-11-22 | 423 | 0 |
| K003995 | SPECULITE/ORALLITE | Trylon Corp. | 2001-03-16 | 80 | 0 |
| K926081 | DENTAL LIGHT | Mdt Corp., Inc. | 1994-01-26 | 421 | 0 |
| K935390 | SIROLUX FANTASTIC | Pelton & Crane Co. | 1993-12-10 | 32 | 0 |
| K925629 | ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT | Den-Tal-Ez Mfg Co., Inc. | 1993-11-23 | 382 | 0 |
| K923462 | DELIGHT | Planmeca USA, Inc. | 1992-12-21 | 160 | 0 |
| K912142 | MICRONAIRE ISO-HOOD MAX 5UV | Micronaire Corp. | 1991-10-30 | 169 | 0 |
| K912997 | MINIFLEX AND PERSONAL UNIT | Dabi-Atlante America Corp. | 1991-10-30 | 114 | 0 |
| K902685 | DEFIANCE MODEL FUS 336 | Defiance Electronics, Inc. | 1990-09-17 | 90 | 0 |
| K894059 | ISOLIGHT | Eurodent, Inc. | 1989-09-07 | 92 | 0 |
| K893044 | A-DEC DENTAL LIGHT | A-Dec, Inc. | 1989-07-14 | 81 | 0 |
| K891216 | DENTAL EQUIPMENT PROTECTION DEVICES | Pro-Safe Professional Linens, Inc. | 1989-06-02 | 87 | 0 |
| K884223 | DENTAL LAMP HANDLE COVER | Steri-Shield Products, Inc. | 1989-03-17 | 162 | 0 |
| K874374 | THE WOOG ORATEST | Woog Intl. | 1988-01-19 | 85 | 0 |
| K863019 | F-11 REFLECTOR / F-II STANDARD REFLECTOR | Sds Dental, Inc. | 1986-09-29 | 52 | 0 |
| K832919 | OPTI-BEAM IV | Dentsply Intl. | 1984-03-02 | 190 | 0 |
| K801683 | LUNA-VUE DENTAL OPERATING LIGHT | Pacific Dental Corp. | 1980-08-04 | 14 | 0 |
| K790984 | KLIP-LITE | Innovators, Inc. | 1979-10-22 | 150 | 0 |
| K772351 | DENTAL LIGHT | Chemetron Dental Products | 1978-01-17 | 26 | 0 |
| K771249 | JOY LIGHT | M.D. Intl., Inc. | 1977-07-15 | 8 | 0 |
| K760707 | RITTER STARLIGHT DENTAL OPERATING LIGHT | Ritter Co. | 1976-10-05 | 12 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda