Ormco Corp.: FDA filings under this applicant name
FDA lists 46 510(k) clearances under 2 spellings of the applicant name “Ormco Corp.” (first 1978, latest 2025), across 14 product codes in 1 review panel. Median 510(k) review time under this name: 77 days. Since 2017 the median was 59 days, against 197 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Envista (Nobel Biocare, Ormco, Kerr), based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 78 |
| 2013 | 3 | 174 |
| 2014 | 1 | 172 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 28 |
| 2018 | 1 | 134 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 90 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 233 |
| 2025 | 2 | 1 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ormco Corp. took a median 59 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 197 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 10 | 10 |
| DYW | Bracket, Plastic, Orthodontic | 9 | 9 |
| EJF | Bracket, Metal, Orthodontic | 8 | 8 |
| DZB | Headgear, Extraoral, Orthodontic | 4 | 4 |
| NJM | Bracket, Ceramic, Orthodontic | 3 | 3 |
| NXC | Aligner, Sequential | 3 | 3 |
| NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | 2 | 2 |
| DZC | Wire, Orthodontic | 1 | 1 |
| DZE | Implant, Endosseous, Root-Form | 1 | 1 |
| ECO | Spring, Orthodontic | 1 | 1 |
Plus 4 more product codes.
Review panels
- Dental (46)
Most recent Ormco Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250487 | SparkTM Clear Aligner System | NXC | 2025-02-20 | 1 |
| K250015 | Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive | DYH | 2025-01-03 | 1 |
| K240501 | Spark Clear Aligner System | NXC | 2024-10-11 | 233 |
| K203737 | Spark Clear Aligner System | NXC | 2021-03-22 | 90 |
| K172845 | Symetri Clear | NJM | 2018-01-31 | 134 |
| K171844 | Inspire ICE aka Inspire ICE Clear Brackets | NJM | 2017-07-18 | 28 |
| K141611 | LYTHOS DIGITAL IMPRESSION SYSTEM | NOF | 2014-12-05 | 172 |
| K123118 | INSIGNIA DIGICAST | DYW | 2013-03-26 | 174 |
| K123416 | INSIGNIA WITH ITERO | DYW | 2013-03-13 | 127 |
| K122065 | DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE | NOF | 2013-02-08 | 210 |
36 earlier clearances. See the full list in Caduvo.
Recalls
11 product recalls in 9 recall events; 0 initiated in the last five years. Most recent: 2011-05-18.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Ormco Corp. (40)
- Ormco Corporation (6)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ormco Corp.?
FDA lists 46 510(k) clearances under 2 spellings of the applicant name “Ormco Corp.” (first 1978, latest 2025), across 14 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ormco Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ormco Corp. is 77 days. Since 2017: 59 days, versus 197 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ormco Corp.?
The most frequent FDA product codes under this applicant name are DYH (Adhesive, Bracket And Tooth Conditioner, Resin, 10); DYW (Bracket, Plastic, Orthodontic, 9); EJF (Bracket, Metal, Orthodontic, 8).
Next steps
- See all 46 Ormco Corp. clearances with predicates and recalls
- Run predicate analysis for product code DYH, Ormco Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.