Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EHZ — Predicate Candidate Screening
17 FDA 510(k) clearances under this product code; the 50 most recent screened below.
65 daysmedian FDA review time
82 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K973248 | IMTEC BONE COLLECTOR SYSTEM | Imtec Corp. | 1997-11-19 | 82 | 0 |
| K941164 | TAP EXPRESS EJECTOR | Tap Express, Inc. | 1994-05-18 | 68 | 0 |
| K911072 | SUPER EVACRETRACTOR, DISPOSABLE ORAL EVACUATOR | A & F Products | 1991-05-15 | 65 | 0 |
| K903718 | OROSCOPE MODEL NUMBER COS-100 | Cygnus Instruments, Inc. | 1990-11-09 | 85 | 0 |
| K892882 | DENTAL SANI-SLEEVE STERILE 100MM X 2200MM #1102 | Nieusma R & D, Inc. | 1989-06-23 | 78 | 0 |
| K892881 | DENTAL SANI-SLEEVE STERILE 60MM X 1650MM #1101 | Nieusma R & D, Inc. | 1989-06-23 | 78 | 0 |
| K880754 | DRI-CLAVE LIQUID KLEENZALL | Columbus Dental Mfg. Co. | 1988-05-12 | 77 | 0 |
| K873545 | PORTABLE FIELD DENTAL OPERATING & TREATMENT UNIT | Commercial Products & Engineering Co. | 1987-11-20 | 80 | 0 |
| K874401 | TITANIUM SUCTION TIP | Implant Innovations International, Inc. | 1987-11-12 | 15 | 0 |
| K864621 | VAC - RITE RIGHT ANGLE ASPIRATOR TUBE & HOLDER | Seldoren , Ltd. | 1987-02-13 | 81 | 0 |
| K863769 | EVACUATOR TIPS | The Medical Group, Inc. | 1986-10-30 | 35 | 0 |
| K801682 | SPACELINE HIGH VOLUME EVACUATION HANDPIE | Pacific Dental Corp. | 1980-08-04 | 14 | 0 |
| K782068 | MVS UNIT, MODEL SEU-8 AND DEU-8, 80 | Dentsply Intl. | 1979-01-26 | 44 | 0 |
| K781488 | MVS-MODEL SEU-6, DEU-6 | Dentsply Intl. | 1978-09-27 | 30 | 0 |
| K781486 | STERI-VAC POWER UNITS | Cpac, Inc. | 1978-09-27 | 30 | 0 |
| K780701 | DENTAL OFFICE ENVIRONMENT CONTROL UNIT | Laminaire Corp. | 1978-05-16 | 20 | 0 |
| K770152 | AUTO-RINSE | Dental Innovators, Inc. | 1977-01-31 | 7 | 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