510(k) Report

510(k) · Cleared

Cleared

Dentaurum Space Maintainer

K935856510(k) TraditionalCleared Apr 28, 1994141-day reviewClass I21 CFR 872.5525

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

Dentauraum, Inc. · DYT Maintainer, Space Preformed, Orthodontic

Cleared on Apr 28, 1994 after a 141-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Apr 28, 1994
Review
141 days
Class
Class I
Product code
DYT
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 K935856Source: 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.

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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 DYT devices

DYT Maintainer, Space Preformed, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DYT

FDA has decided no DYT device since 2007.

Median 510(k) review, days · DYT

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

Recalls per year · DYT

No recall names DYT since 2007.

Adverse event reports per year · DYT

9in 2025

2016: 12017: 42018: 52019: 82020: 22021: 12022: 82023: 142024: 132025: 9
2007high 14 (2023) · low 0 (2007)2025

MAUDE reports naming product code DYT, 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—00
20130—00
20140—00
20150—00
20160—01
20170—04
20180—05
20190—08
20200—02
20210—01
20220—08
20230—014
20240—013
20250—09
20260—0—

More from Dentauraum, Inc.

24 FDA decisions under this applicant name. See the company

  • K952866Rematitan TitaniumDentauraum, Inc. · 1995
  • K952870Remanium: CS & G-SoftDentauraum, Inc. · 1995
  • K952867Remanium:GM 700, GM 380, GM 800, GFHDentauraum, Inc. · 1995
  • K952865Remanium: 200,CS, 380, and CDDentauraum, Inc. · 1995
  • K952868Dentaurum Jacket Crown & Root PostsDentauraum, Inc. · 1995

Recent decisions in DYT

The DYT category page

  • K864376FiberbondDentec, Inc. · 1987
  • K812239Unitek Palatal BarUnitek Corp. · 1981
  • K780814Safety Stop NeckstrapNorthwest Orthodontics, Inc. · 1978

https://510kreport.com/device/K935856 · printed Nov 4, 2026

Cite this page

510(k) Report. “K935856: Dentaurum Space Maintainer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K935856

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