Alpine Dental Equipment Co.: FDA clearances and approvals
Alpine Dental Equipment Co. has 10 FDA 510(k) clearances (first 1986, latest 1988), across 5 product codes in 2 review panels. Median 510(k) review time: 114 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 |
|---|---|---|---|
| KLC | Chair, Dental, With Operative Unit | 4 | 4 |
| EIA | Unit, Operative Dental | 3 | 3 |
| EBA | Light, Surgical Headlight | 1 | 1 |
| EFB | Handpiece, Air-Powered, Dental | 1 | 1 |
| EHD | Unit, X-Ray, Extraoral With Timer | 1 | 1 |
Review panels
Most recent Alpine Dental Equipment Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K880475 | SKEMA (DENTAL UNIT) | KLC | 1988-09-23 | 232 |
| K880474 | AREA (DENTAL CHAIR) | KLC | 1988-09-23 | 232 |
| K854647 | POLO DENTAL UNIT | KLC | 1986-06-05 | 198 |
| K854643 | SOLAR | EIA | 1986-03-14 | 115 |
| K854642 | SOLAR CART | EIA | 1986-03-14 | 115 |
| K854645 | GOLD AIR, GOLD LIGHT | EFB | 1986-03-12 | 113 |
| K854641 | SOLAR F | EIA | 1986-03-10 | 111 |
| K854741 | X-RANGE 65 | EHD | 1986-03-06 | 101 |
| K854646 | VEGA DENTAL OPERATING LIGHT | EBA | 1986-03-06 | 107 |
| K854644 | MANTA DENTAL CHAIR | KLC | 1986-01-23 | 65 |
Recalls
openFDA lists no recalls under a recalling firm named Alpine Dental Equipment Co..
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 Alpine Dental Equipment Co. have?
Alpine Dental Equipment Co. has 10 FDA 510(k) clearances (first 1986, latest 1988), across 5 product codes in 2 review panels.
How long does FDA take to clear Alpine Dental Equipment Co.'s 510(k)s?
The median time from FDA receipt to decision across Alpine Dental Equipment Co.'s cleared 510(k)s is 114 days.
What devices does Alpine Dental Equipment Co. make?
Its most frequent FDA product codes are KLC (Chair, Dental, With Operative Unit, 4); EIA (Unit, Operative Dental, 3); EBA (Light, Surgical Headlight, 1).
Has Alpine Dental Equipment Co. had device recalls?
openFDA lists no recalls under a recalling firm name matching Alpine Dental Equipment Co. Related entities may recall under other names.
Next steps
- See all 10 Alpine Dental Equipment Co. clearances with predicates and recalls
- Run predicate analysis for product code KLC, Alpine Dental Equipment Co.'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.