Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Ormco Corp. — Predicate Candidate Screening
40 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
78 daysmedian FDA review time
174 days90th percentile
40clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K141611 | LYTHOS DIGITAL IMPRESSION SYSTEM | Ormco Corp. | 2014-12-05 | 172 | 0 |
| K123118 | INSIGNIA DIGICAST | Ormco Corp. | 2013-03-26 | 174 | 0 |
| K123416 | INSIGNIA WITH ITERO | Ormco Corp. | 2013-03-13 | 127 | 0 |
| K122065 | DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE | Ormco Corp. | 2013-02-08 | 210 | 0 |
| K121524 | INSIGNIA | Ormco Corp. | 2012-08-09 | 78 | 0 |
| K112640 | HYPERELASTIC WIRE | Ormco Corp. | 2011-11-16 | 65 | 0 |
| K101676 | CLEARARCH | Ormco Corp. | 2010-09-13 | 90 | 0 |
| K081900 | TEMPORARY TOOTH REPLACEMENT | Ormco Corp. | 2008-10-24 | 113 | 0 |
| K081415 | DAMON 4CLEAR | Ormco Corp. | 2008-09-24 | 127 | 0 |
| K062856 | TF ROTARY NICKEL TITANIUM FILE | Ormco Corp. | 2006-12-13 | 79 | 0 |
| K061481 | GRENGLOO | Ormco Corp. | 2006-07-06 | 37 | 1 |
| K052477 | DAMON 3 MODIFIED | Ormco Corp. | 2005-11-30 | 82 | 2 |
| K955333 | SPIRIT MB | Ormco Corp. | 1996-01-04 | 44 | 0 |
| K951239 | GLOWING SPIRITS | Ormco Corp. | 1995-07-19 | 121 | 0 |
| K951776 | BAND SEATER | Ormco Corp. | 1995-05-23 | 40 | 0 |
| K946255 | THERMASET | Ormco Corp. | 1995-01-27 | 36 | 0 |
| K943068 | MAGNEFORCE | Ormco Corp. | 1994-08-17 | 50 | 0 |
| K941015 | ORMCO SYSTEM 1+ (TM) | Ormco Corp. | 1994-03-31 | 28 | 0 |
| K922806 | ORMCO SPORTSGUARD | Ormco Corp. | 1993-10-20 | 497 | 0 |
| K923405 | THE HERBST APPLIANCE | Ormco Corp. | 1993-05-05 | 299 | 0 |
| K923556 | ADP FACEMASK | Ormco Corp. | 1992-12-04 | 140 | 0 |
| K923399 | CHALLENGE II - PASTE ADHESIVE | Ormco Corp. | 1992-10-27 | 109 | 0 |
| K921245 | THE BRACKET ASSEMBLY W/ SECURITY SYSTEM II | Ormco Corp. | 1992-05-05 | 50 | 0 |
| K921385 | IMPROVED SEQUENCE LIGHT CURE ADHESIVE | Ormco Corp. | 1992-04-21 | 29 | 0 |
| K914727 | SEQUENCE LIGHT CURE ADHESIVE | Ormco Corp. | 1992-01-17 | 88 | 0 |
| K914616 | KLEER(TM) ORTHODONTIC BRACKET | Ormco Corp. | 1991-11-20 | 34 | 0 |
| K905197 | THE BRACKET ASSEMBLY WITH A SECURITY SYSTEM | Ormco Corp. | 1990-12-27 | 37 | 0 |
| K902646 | HOOD GEAR (TM) BREAKAWAY HEADGEAR WITH NECK STRAP | Ormco Corp. | 1990-09-06 | 83 | 0 |
| K902645 | HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULL | Ormco Corp. | 1990-09-06 | 83 | 0 |
| K900184 | LINGUAL SHEATH | Ormco Corp. | 1990-04-02 | 76 | 0 |
| K896913 | SPIRIT | Ormco Corp. | 1990-03-08 | 87 | 0 |
| K894781 | OPTIFLEX | Ormco Corp. | 1989-09-15 | 49 | 0 |
| K894358 | LUMINA ORTHODONTIC BRACKET | Ormco Corp. | 1989-09-15 | 63 | 0 |
| K892704 | GEM II ORTHODONTIC BRACKET | Ormco Corp. | 1989-06-12 | 59 | 0 |
| K890740 | FRS LITE FLUORIDE RELEASING SEALANT | Ormco Corp. | 1989-04-25 | 71 | 0 |
| K870536 | GEM ORTHODONTIC BRACKET | Ormco Corp. | 1987-02-19 | 10 | 0 |
| K863709 | CHALLENGE ORTHODONTIC BONDING ADHESIVE | Ormco Corp. | 1987-01-21 | 120 | 0 |
| K862538 | SENTRY BREAKWAY NECK STRAP | Ormco Corp. | 1986-07-11 | 9 | 0 |
| K852894 | ORMCO TRANSMANDIBULAR IMPLANT | Ormco Corp. | 1985-08-29 | 51 | 0 |
| K780239 | BRACKET, METAL REINFORCED PLASTIC | Ormco Corp. | 1978-03-15 | 30 | 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