Carestream Dental, LLC: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Carestream Dental, LLC” (first 2012, latest 2012), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 34 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 | 1 | 34 |
| 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 1 | 1 |
| MYN | Analyzer, Medical Image | 1 | 0 |
Review panels
- Radiology (2)
Most recent Carestream Dental, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K122427 | CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE | LLZ | 2012-09-12 | 34 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P980025 | PMA | LOGICON CARIES DETECTOR | 1998-09-25 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2021-02-15.
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.
- Carestream Health, Inc. (53 510(k)s)
- Carestream Heatlh, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Carestream Dental, LLC?
FDA lists 1 510(k) clearance under the applicant name “Carestream Dental, LLC” (first 2012, latest 2012), plus 1 PMA decision, across 2 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 Carestream Dental, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Carestream Dental, LLC is 34 days.
Which FDA product codes appear under Carestream Dental, LLC?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 1); MYN (Analyzer, Medical Image, 1).
Next steps
- See all 1 Carestream Dental, LLC clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Carestream Dental, LLC'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.