510(k) · Cleared
ClearedAcclaim
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Air Techniques, Inc. · NRD Unit, Operative Dental, Accessories
Cleared on Aug 31, 2004 after an 8-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 31, 2004
- Review
- 8 days
- Class
- Class I
- Product code
- NRD
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NRD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All NRD devicesNRD Unit, Operative Dental, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NRD
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · NRD
Too few NRD 510(k)s in any year since 2007 to give a median.
Recalls per year · NRD
No recall names NRD since 2007.
Adverse event reports per year · NRD
1in 2022
MAUDE reports naming product code NRD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Acclaim system is primarily a tool to provide visual information to dental patients so they may be better equipped to make decisions about the quantity and quality of the health care they receive.
This is the same intended use as previously cleared for the Vistacam Omni IC, 510(k) number 974204.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K042266 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042266: Acclaim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042266
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026