510(k) Report

510(k) · Cleared

Cleared

Palavit L

K905058510(k) TraditionalCleared Jun 6, 1991210-day reviewClass I21 CFR 872.3670

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

Kulzer, Inc. · EBH Material, Impression Tray, Resin

Cleared on Jun 6, 1991 after a 210-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jun 6, 1991
Review
210 days
Class
Class I
Product code
EBH
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K905058Source: 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 EBH? 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
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What was it cleared against?

FDA has not posted a summary or statement for it, 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 EBH devices

EBH Material, Impression Tray, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EBH

FDA has decided no EBH device since 2007.

Median 510(k) review, days · EBH

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

Recalls per year · EBH

No recall names EBH since 2007.

Adverse event reports per year · EBH

1in 2013

2007: 12010: 12013: 1
2007high 1 (2007) · low 0 (2008)2025

MAUDE reports naming product code EBH, 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—01
20080—00
20090—00
20100—01
20110—00
20120—00
20130—01
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Kulzer, Inc.

31 FDA decisions under this applicant name. See the company

  • K904928Palavit GLCKulzer, Inc. · 1991
  • K910263CharismaKulzer, Inc. · 1991
  • K910719Silicoater MDKulzer, Inc. · 1991
  • K905131Durafill Color VSKulzer, Inc. · 1991
  • K905302DenthesiveKulzer, Inc. · 1991

Recent decisions in EBH

The EBH category page

  • K933745Permagen Universal Bonding ResinBio-Systems Research · 1994
  • K930487Palatray LC MintHeraeus Kulzer, Inc. · 1993
  • K923979LC Tray MaterialDentsply Intl. · 1992
  • K923549Paladisc LCHeraeus Kulzer, Inc. · 1992
  • K912820Polyester Resin Hand Molded TrayE&D Dental Products, Inc. · 1991

https://510kreport.com/device/K905058 · printed Nov 4, 2026

Cite this page

510(k) Report. “K905058: Palavit L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K905058

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