Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Almore Intl., Inc. — Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
48 daysmedian FDA review time
124 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K862851 | ALMORE FACE MASK | Almore Intl., Inc. | 1986-08-12 | 14 | 0 |
| K854692 | MONARCH II BLEACHING INSTRUMENT | Almore Intl., Inc. | 1986-05-12 | 172 | 0 |
| K854696 | OP II VISIBLE LIGHT CURING SYSTEM | Almore Intl., Inc. | 1986-03-26 | 125 | 0 |
| K854690 | DIAMONDS BURS-COMPOSIT FINISHING | Almore Intl., Inc. | 1986-03-25 | 124 | 0 |
| K854691 | DIAMOND BURS-HANDPIECE | Almore Intl., Inc. | 1986-03-25 | 124 | 0 |
| K854700 | EZ-ON TUBING CONDITIONER (LUBRICANT) | Almore Intl., Inc. | 1986-03-12 | 111 | 0 |
| K854702 | PLASTIC MOUNTING RINGS | Almore Intl., Inc. | 1986-03-06 | 105 | 0 |
| K854697 | TUBING HANDPIECE REPLACEMENT | Almore Intl., Inc. | 1986-03-06 | 105 | 0 |
| K854701 | RETRACT-A-CORD | Almore Intl., Inc. | 1986-03-06 | 105 | 0 |
| K854699 | TUBING SYRING | Almore Intl., Inc. | 1986-01-06 | 46 | 0 |
| K831136 | DOUBLE BOW TOOTH SEPARATOR | Almore Intl., Inc. | 1983-06-08 | 62 | 0 |
| K831137 | STRAIGHT 5 HEMOSTAT | Almore Intl., Inc. | 1983-05-18 | 41 | 0 |
| K831138 | CURVED HEMOSTAT 5 | Almore Intl., Inc. | 1983-05-18 | 41 | 0 |
| K830775 | FACEBOW FOR BALANCE ARTICULATOR | Almore Intl., Inc. | 1983-04-28 | 48 | 0 |
| K830776 | MICROFIL CONTOURING INSTRUMENTS | Almore Intl., Inc. | 1983-04-28 | 48 | 0 |
| K830773 | MARKLEY THREADED WIRE | Almore Intl., Inc. | 1983-04-28 | 48 | 0 |
| K830774 | BINOCULAR MAGNIFIER 2X | Almore Intl., Inc. | 1983-04-06 | 26 | 0 |
| K830777 | ELECTRIC MOUTH MIRROR | Almore Intl., Inc. | 1983-04-06 | 26 | 0 |
| K830878 | BINOCULAR LOUPE | Almore Intl., Inc. | 1983-04-06 | 19 | 0 |
| K811075 | BALANCE ARTICULATOR | Almore Intl., Inc. | 1981-05-13 | 23 | 0 |
| K801463 | OJ-1 ENDODONIC ROOT CANAL FILE HOLDER | Almore Intl., Inc. | 1980-07-21 | 27 | 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