Lancer Orthodontics, Inc.: FDA clearances and approvals
Lancer Orthodontics, Inc. has 14 FDA 510(k) clearances (first 1990, latest 2013), across 8 product codes in 1 review panel. Median 510(k) review time: 77 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 269 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EJF | Bracket, Metal, Orthodontic | 7 | 7 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 1 | 1 |
| DZB | Headgear, Extraoral, Orthodontic | 1 | 1 |
| DZE | Implant, Endosseous, Root-Form | 1 | 1 |
| EJJ | Alloy, Amalgam | 1 | 1 |
| ELW | Material, Impression | 1 | 1 |
| NJM | Bracket, Ceramic, Orthodontic | 1 | 1 |
| OAT | Implant, Endosseous, Orthodontic | 1 | 1 |
Review panels
- Dental (14)
Most recent Lancer Orthodontics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K122069 | STORM MINI SCREW | OAT | 2013-04-11 | 269 |
| K071192 | BLUGOO HD | ELW | 2007-06-22 | 53 |
| K051552 | O.A.S.I. SYSTEM | DZE | 2005-09-19 | 98 |
| K991481 | PARAGON | EJJ | 1999-08-11 | 105 |
| K904090 | ORTHODONTIC BONDING ADHESIVE CONTROL | DYH | 1991-04-29 | 235 |
| K904092 | LANCER ORIGINAL, SIERRA, GENERAL PURPOSE | EJF | 1990-11-09 | 64 |
| K904093 | BUCCAL TUBE, BUCCAL ATTACHMENT | EJF | 1990-11-07 | 62 |
| K904091 | TITANAL,STERLING SPRING,DUAL FLEX,MEMOREX,BENDALLO | EJF | 1990-11-05 | 60 |
| K904094 | C.A.T.,SINTERLINE,NATURAL ARCH,MICROTWIN,BIOTORQUE | EJF | 1990-11-02 | 57 |
| K904089 | PERMA MESH | EJF | 1990-11-02 | 57 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Lancer Orthodontics, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Lancer Orthodontics, Inc. have?
Lancer Orthodontics, Inc. has 14 FDA 510(k) clearances (first 1990, latest 2013), across 8 product codes in 1 review panel.
How long does FDA take to clear Lancer Orthodontics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Lancer Orthodontics, Inc.'s cleared 510(k)s is 77 days.
What devices does Lancer Orthodontics, Inc. make?
Its most frequent FDA product codes are EJF (Bracket, Metal, Orthodontic, 7); DYH (Adhesive, Bracket And Tooth Conditioner, Resin, 1); DZB (Headgear, Extraoral, Orthodontic, 1).
Has Lancer Orthodontics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Lancer Orthodontics, Inc. Related entities may recall under other names.
Next steps
- See all 14 Lancer Orthodontics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EJF, Lancer Orthodontics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.