510(k) · Cleared
ClearedPerio Control II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Estrad B.V. · EIK Carver, Wax, Dental
Cleared on Jan 26, 1998 as substantially equivalent to K875076 (Florida Probe Corp., 1988) after a 195-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Jan 26, 1998
- Review
- 195 days
- Class
- Class I
- Product code
- EIK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K875076 (1988). No later device cites it as a predicate yet.
- Root · 1 generation backK875076 Florida ProbeFlorida Probe Corp. · 1988
- This deviceK972642 Perio Control IIEstrad B.V. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K875076 | Florida Probe | Florida Probe Corp. | 1988 | — |
| 0 (this device) | K972642 | Perio Control II | Estrad B.V. | 1998 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EIK? 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K875076 | Florida ProbeSummary page 1…e: Electronic Periodontal Probe Measuring Device Equivalent legally marketed devices This product is similar in design and function to the FLORIDA PROBE. 510(k) Number: K875076 Indications for Use (intended use) The intended use of the "Perio Control II™" device is to screen patients and to track diseas… | 1988 |
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.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K875076.
How does its category compare?
All EIK devicesEIK Carver, Wax, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EIK
FDA has decided no EIK device since 2007.
Median 510(k) review, days · EIK
Too few EIK 510(k)s in any year since 2007 to give a median.
Recalls per year · EIK
No recall names EIK since 2007.
Adverse event reports per year · EIK
No MAUDE report names EIK since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 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 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Perio Control IT is used during periodontal examination to measure gingival pocket depth. The pocket depth is displayed on the electronics unit and can be entered in an external computer system, either a PC or a Psion Series 3C. Also, the eventual occurrence of bleeding on probing can be registered, as well as the presence of supra-gingival plaque. This is judged visually and registered by pressing one of the buttons on the "Perio Control II"™…
Read the full statement (176 words)
The Perio Control IT is used during periodontal examination to measure gingival pocket depth. The pocket depth is displayed on the electronics unit and can be entered in an external computer system, either a PC or a Psion Series 3C.
Also, the eventual occurrence of bleeding on probing can be registered, as well as the presence of supra-gingival plaque. This is judged visually and registered by pressing one of the buttons on the "Perio Control II"™ handpiece.
The pocket depth is measured by entering the probe tip into the gingival pocket and forcing the filament-of the probe up into the sleeve until the sleeve is at a specific reference point. In this position one of the buttons on the "Perio Control II™" handpiece is pressed. The pocket depth is now displayed on the electronics unit.
The intended use of the "Perio Control II™" device is to screen.patients and to track disease progression in the target population of patients who are suspected of having or already have periodontal disease. Both pediatric and adult patients may be tested.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972642 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972642: Perio Control II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972642
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026