510(k) Report

510(k) · Cleared

Cleared

Facebow for Balance Articulator

K830775510(k) TraditionalCleared Apr 28, 198348-day reviewClass I21 CFR 872.3220

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

Almore Intl., Inc. · KCR Facebow

Cleared on Apr 28, 1983 after a 48-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Apr 28, 1983
Review
48 days
Class
Class I
Product code
KCR
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K830775Source: 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 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 KCR devices

KCR Facebow: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KCR

FDA has decided no KCR device since 2007.

Median 510(k) review, days · KCR

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

Recalls per year · KCR

No recall names KCR since 2007.

Adverse event reports per year · KCR

No MAUDE report names KCR since 2007.

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—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Almore Intl., Inc.

21 FDA decisions under this applicant name. See the company

  • K862851Almore Face MaskAlmore Intl., Inc. · 1986
  • K854692Monarch II Bleaching InstrumentAlmore Intl., Inc. · 1986
  • K854696OP II Visible Light Curing SystemAlmore Intl., Inc. · 1986
  • K854691Diamond Burs-HandpieceAlmore Intl., Inc. · 1986
  • K854690Diamonds Burs-Composit FinishingAlmore Intl., Inc. · 1986

https://510kreport.com/device/K830775 · printed Nov 6, 2026

Cite this page

510(k) Report. “K830775: Facebow for Balance Articulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K830775

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