Steri-Shield Products, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Steri-Shield Products, Inc.” (first 1989, latest 1989), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 162 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 |
|---|---|---|---|
| EAZ | Light, Operating, Dental | 1 | 1 |
| EBZ | Activator, Ultraviolet, For Polymerization | 1 | 1 |
| EFS | Unit, Oral Irrigation | 1 | 1 |
| EIA | Unit, Operative Dental | 1 | 1 |
| ELC | Scaler, Ultrasonic | 1 | 1 |
Review panels
- Dental (5)
Most recent Steri-Shield Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K884223 | DENTAL LAMP HANDLE COVER | EAZ | 1989-03-17 | 162 |
| K884222 | CURING LIGHT COVER | EBZ | 1989-03-17 | 162 |
| K884221 | ULTRASONIC SCALER COVER | ELC | 1989-03-17 | 162 |
| K884220 | AIR WATER SYRINGE TIP SHIELD | EFS | 1989-03-17 | 162 |
| K884219 | BRACKET TABLE ARM COVER | EIA | 1989-03-17 | 162 |
Recalls
openFDA lists no recalls under a recalling firm named Steri-Shield Products, Inc..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Steri-Oss, Inc. (46 510(k)s)
- Steri-Aid, Inc. (1 510(k)s)
- Steri-Sol, Inc. (1 510(k)s)
- Steri-Sytems, Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Steri-Shield Products, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Steri-Shield Products, Inc.” (first 1989, latest 1989), across 5 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 Steri-Shield Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Steri-Shield Products, Inc. is 162 days.
Which FDA product codes appear under Steri-Shield Products, Inc.?
The most frequent FDA product codes under this applicant name are EAZ (Light, Operating, Dental, 1); EBZ (Activator, Ultraviolet, For Polymerization, 1); EFS (Unit, Oral Irrigation, 1).
Next steps
- See all 5 Steri-Shield Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EAZ, Steri-Shield Products, Inc.'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.