510(k) Report

510(k) · Cleared

Cleared

Micodose Chlorhexiprep

K925163510(k) TraditionalCleared May 27, 1993226-day reviewClass I21 CFR 872.5410

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Unicep · ECM Band, Preformed, Orthodontic

Cleared on May 27, 1993 after a 226-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
May 27, 1993
Review
226 days
Class
Class I
Product code
ECM
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K925163Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in ECM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

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 ECM devices

ECM Band, Preformed, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ECM

FDA has decided no ECM device since 2007.

Median 510(k) review, days · ECM

Too few ECM 510(k)s in any year since 2007 to give a median.

Recalls per year · ECM

No recall names ECM since 2007.

Adverse event reports per year · ECM

2in 2022

2012: 12022: 2
2007high 2 (2022) · low 0 (2007)2025

MAUDE reports naming product code ECM, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—01
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—02
20230—00
20240—00
20250—00
20260—0—

More from Unicep

9 FDA decisions under this applicant name. See the company

  • K924823Microdose SilaneUnicep · 1993
  • K924824Microdose Pit and Fissure Sealant-Clear or WhiteUnicep · 1993
  • K925162Microdose Dentin ConditionerUnicep · 1993
  • K924821Microdose Porcelain EtchantUnicep · 1993
  • K924826Microdose Total EtchantUnicep · 1993

Recent decisions in ECM

The ECM category page

  • K872471Titane SL Dental BurrTitane SL Co. · 1987

https://510kreport.com/device/K925163 · printed Nov 5, 2026

Cite this page

510(k) Report. “K925163: Micodose Chlorhexiprep.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K925163

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026