Wallace A. Erickson & Co.: FDA filings under this applicant name
FDA lists 32 510(k) clearances under the applicant name “Wallace A. Erickson & Co.” (first 1978, latest 1999), across 11 product codes in 1 review panel. Median 510(k) review time under this name: 72 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 7 | 7 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 5 | 5 |
| ELW | Material, Impression | 4 | 4 |
| EMA | Cement, Dental | 4 | 4 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 3 | 3 |
| KLE | Agent, Tooth Bonding, Resin | 3 | 3 |
| KIF | Resin, Root Canal Filling | 2 | 2 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 1 | 1 |
| EFH | Paper, Articulation | 1 | 1 |
Plus 1 more product codes.
Review panels
- Dental (32)
Most recent Wallace A. Erickson & Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K984503 | ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000 | KLE | 1999-02-26 | 70 |
| K963922 | ALPHA-DENT ROOT CANAL SEALER & FILLER | KIF | 1996-12-06 | 67 |
| K960667 | CENTRIX FLOFIL/CENTRIX FLOFIL WITH FLUORIDE | EBF | 1996-07-02 | 133 |
| K960365 | ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000) | KLE | 1996-03-28 | 63 |
| K960165 | ALPHA-DENT COMPOSITE SURFACE SEALANT | EBF | 1996-03-15 | 59 |
| K960122 | ALPHA-DENT TEMPORARY CROWN AND BRIDGE MATERIAL | EBG | 1996-02-21 | 36 |
| K955521 | ALPHA-DENT COPAL CAVITY VARNISH | LBH | 1996-01-24 | 51 |
| K955089 | ALPHA-DENT ZINC OXIDE EUGENOL TEMPORARY CEMENT | EMA | 1995-12-13 | 36 |
| K942742 | ALPHA BOND-RITE II(TM) OR BOND-RITE II(TM) 2-PASTE ADHEV | DYH | 1994-08-29 | 80 |
| K942727 | ALPHA BOUND-RITE I NO-MIX ADHESIVE OR BOND-RITE I NO-MIX ADHESIVE | DYH | 1994-08-23 | 75 |
22 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Wallace A. Erickson & Co..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Wallace A. Erickson & Co.?
FDA lists 32 510(k) clearances under the applicant name “Wallace A. Erickson & Co.” (first 1978, latest 1999), across 11 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 Wallace A. Erickson & Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Wallace A. Erickson & Co. is 72 days.
Which FDA product codes appear under Wallace A. Erickson & Co.?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 7); DYH (Adhesive, Bracket And Tooth Conditioner, Resin, 5); ELW (Material, Impression, 4).
Next steps
- See all 32 Wallace A. Erickson & Co. clearances with predicates and recalls
- Run predicate analysis for product code EBF, Wallace A. Erickson & Co.'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.