Lorvic Corp.: FDA clearances and approvals
Lorvic Corp. has 6 FDA 510(k) clearances (first 1976, latest 1987), across 6 product codes in 2 review panels. Median 510(k) review time: 13 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 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 |
|---|---|---|---|
| DYN | Mouthpiece, Saliva Ejector | 1 | 1 |
| EFN | Cotton, Roll | 1 | 1 |
| EJK | Liner, Cavity, Calcium Hydroxide | 1 | 1 |
| KMH | Sterilizer, Dry Heat | 1 | 1 |
| KMT | Tray, Fluoride, Disposable | 1 | 1 |
Plus 1 more product codes.
Review panels
- Dental (4)
- General Hospital (1)
Most recent Lorvic Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K871615 | U. V. GERMICIDAL UNIT | KMH | 1987-09-11 | 137 |
| K780263 | SHIELD | EJK | 1978-05-03 | 75 |
| K770064 | FLUORIDE GEL DISPOSABLE TRAY | KMT | 1977-01-14 | 3 |
| K770063 | DISP. ABSORBENT COMPRESSED FIBRE WAFER | EFN | 1977-01-14 | 3 |
| K760620 | SALIVA EJECTOR | DYN | 1976-09-21 | 8 |
| K760121 | IMPULSE HEAT SEALER | — | 1976-07-16 | 18 |
Recalls
openFDA lists no recalls under a recalling firm named Lorvic Corp..
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 Lorvic Corp. have?
Lorvic Corp. has 6 FDA 510(k) clearances (first 1976, latest 1987), across 6 product codes in 2 review panels.
How long does FDA take to clear Lorvic Corp.'s 510(k)s?
The median time from FDA receipt to decision across Lorvic Corp.'s cleared 510(k)s is 13 days.
What devices does Lorvic Corp. make?
Its most frequent FDA product codes are DYN (Mouthpiece, Saliva Ejector, 1); EFN (Cotton, Roll, 1); EJK (Liner, Cavity, Calcium Hydroxide, 1).
Has Lorvic Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Lorvic Corp. Related entities may recall under other names.
Next steps
- See all 6 Lorvic Corp. clearances with predicates and recalls
- Run predicate analysis for product code DYN, Lorvic Corp.'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.