510(k) · Cleared
ClearedPefect Shot
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Imaging Electronics · EIA Unit, Operative Dental
Cleared on Jul 3, 1997 after a 32-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jul 3, 1997
- Review
- 32 days
- Class
- Class I
- Product code
- EIA
- 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 EIA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EIA device
- #1 K231845 Dental unit Model: Marescore 14.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 EIA devicesEIA Unit, Operative Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EIA
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EIA
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EIA
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EIA
47in 2025
MAUDE reports naming product code EIA, 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 | 3 | 90 | 0 | 0 |
| 2008 | 6 | 72 | 0 | 0 |
| 2009 | 3 | 109 | 0 | 0 |
| 2010 | 3 | 270 | 0 | 2 |
| 2011 | 5 | 150 | 0 | 3 |
| 2012 | 2 | — | 1 | 7 |
| 2013 | 2 | — | 1 | 6 |
| 2014 | 2 | — | 0 | 255 |
| 2015 | 7 | 214 | 0 | 452 |
| 2016 | 4 | 182 | 0 | 151 |
| 2017 | 1 | — | 0 | 64 |
| 2018 | 2 | — | 0 | 73 |
| 2019 | 2 | — | 0 | 68 |
| 2020 | 1 | — | 0 | 48 |
| 2021 | 0 | — | 0 | 49 |
| 2022 | 3 | 265 | 0 | 44 |
| 2023 | 3 | 686 | 0 | 53 |
| 2024 | 3 | 251 | 0 | 53 |
| 2025 | 7 | 178 | 0 | 47 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Perfect Shot Intra-Oral Cameéra is to be used by medical practitioners, usually dental hygienists, assistants or dentists, to view the mouth of patients. It can explore the entire mouth and examine teeth or.gum tissue for diagnostic purposes. It is distributed through dealers to medical practitioners. The Perfect Shot is wireless, unlike other similar devicas, allowing more freedam of movement by the user. It also contains voice activated…
Read the full statement (226 words)
The Perfect Shot Intra-Oral Cameéra is to be used by medical practitioners, usually dental hygienists, assistants or dentists, to view the mouth of patients. It can explore the entire mouth and examine teeth or.gum tissue for diagnostic purposes. It is distributed through dealers to medical practitioners.
The Perfect Shot is wireless, unlike other similar devicas, allowing more freedam of movement by the user. It also contains voice activated instructions which enable the user to “freeze” a view on the monitor or take a picture (capture and print) of the area being examined for reference at a later date by simply using voice instructions.
The product is designed to transmit a RF (radio frequency) signal to a receiver. This product can and will be used both intra and extra orally, which will allow a dentist to examine and display to the patient problem areas of concern or treatment that is required. The resolution capabilities of the CCD (Charge Coupled Device) is 640480 lines.
The picture is transmitted to a monitor in the examination area for the patient to view, allowing the patient a better undarstanding of a potential problem and a better explanation of the prescribed solution.
Pictures that are captured-may be printed for further review or for patient files. The Perfect Shot may also be attached to computers for digital storage or transmission to other computers.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972019 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972019: Pefect Shot.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972019
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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