510(k) Report

510(k) · Cleared

Cleared

Preformed Tooth Positioner

K780619510(k) TraditionalCleared Jun 28, 197876-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

Tp Laboratories, Inc. · KMY Positioner, Tooth, Preformed

Cleared on Jun 28, 1978 after a 76-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 136 later devices descend from it.

Decided
Jun 28, 1978
Review
76 days
Class
Class I
Product code
KMY
Recalls
None
Predicates
0

136 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared2006: 1 descendant cleared2013: 3 descendants cleared2009: 2 descendants cleared2008: 2 descendants cleared2019: 15 descendants cleared2007: 2 descendants cleared2020: 15 descendants cleared2014: 1 descendant cleared2016: 1 descendant cleared2012: 2 descendants cleared2023: 13 descendants cleared2018: 10 descendants cleared2015: 2 descendants cleared2017: 3 descendants cleared2021: 18 descendants cleared2022: 16 descendants cleared2024: 14 descendants cleared2025: 10 descendants cleared2026: 5 descendants cleared19801990200020102020
  1. This deviceK780619 Preformed Tooth PositionerTp Laboratories, Inc. · 1978
  2. Descendant · cites it directly · 135 of its ownK981095 Align SystemAlign Technology · 1998
  3. Descendant · 2 generations on · 82 of its ownK081960 Invisalign SystemAlign Technology · 2008
  4. Descendant · 2 generations on · 67 of its ownK071970 Clear Image AlignerSpecialty Appliance Works, Inc. · 2007
  5. Descendant · 2 generations on · 64 of its ownK082556 ClearcorrectClearcorrect, Inc. · 2009
  6. Descendant · 3 generations on · 60 of its ownK113618 Clearcorrect SystemClearcorrect, Inc. · 2012

Showing 5 of 136 descendants. See all descendants

Descendants cleared per year

1998: 12006: 12007: 22008: 22009: 22012: 22013: 32014: 12015: 22016: 12017: 32018: 102019: 152020: 152021: 182022: 162023: 132024: 142025: 102026: 5
1998high 18 (2021) · low 0 (1999)2026

Most influential descendants

Showing 5 of 136 · See all
  • K981095Align SystemAlign Technology · 1998 · cites it directly135descendants
  • K081960Invisalign SystemAlign Technology · 2008 · 2 generations on82descendants
  • K071970Clear Image AlignerSpecialty Appliance Works, Inc. · 2007 · 2 generations on67descendants
  • K082556ClearcorrectClearcorrect, Inc. · 2009 · 2 generations on64descendants
  • K113618Clearcorrect SystemClearcorrect, Inc. · 2012 · 3 generations on60descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K780619Preformed Tooth PositionerTp Laboratories, Inc.1978—
+1K981095Align SystemAlign Technology1998—
+2K081960Invisalign SystemAlign Technology2008—
+2K071970Clear Image AlignerSpecialty Appliance Works, Inc.2007—
+2K082556ClearcorrectClearcorrect, Inc.2009—
+3K113618Clearcorrect SystemClearcorrect, Inc.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200610
200720
200820
200920
201220
201330
201410
201520
201610
201730
2018100
2019150
2020150
2021180
2022160
2023130
2024140
2025100
202650
FIG. 1 — Lineage of K780619, 1978–2026Source: FDA 510(k) summaries, read by 510(k) Report · 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 KMY? 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? (136)

See all 136

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K981095Align SystemAlign Technology1998135

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?

  • Of its descendants, K981095 (Align Technology, 1998) has gone furthest, with 135 descendants of its own.

How does its category compare?

All KMY devices

KMY Positioner, Tooth, Preformed: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KMY

FDA has decided no KMY device since 2007.

Median 510(k) review, days · KMY

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

Recalls per year · KMY

No recall names KMY since 2007.

Adverse event reports per year · KMY

452in 2025

2007: 12008: 22009: 32010: 22011: 32012: 22013: 22015: 22016: 22018: 52019: 32021: 712022: 192023: 42024: 3762025: 452
2007high 452 (2025) · low 0 (2014)2025

MAUDE reports naming product code KMY, 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—02
20090—03
20100—02
20110—03
20120—02
20130—02
20140—00
20150—02
20160—02
20170—00
20180—05
20190—03
20200—00
20210—071
20220—019
20230—04
20240—0376
20250—0452
20260—0—

Recent decisions in KMY

The KMY category page

  • K931615Nite-GuideORTHO-TAIN, Inc. · 1995
  • K942667Dent-O-Cryl Orthodontic AcrylicDentauraum, Inc. · 1995
  • K924351Glenroe Elastibite StimulatorGlenroe Technologies · 1994
  • K925064Relax-O-GuardAquatemp Service Co., Inc. · 1993
  • K924975The OrthotrainerMyofunctional Research Corp. Pty., Ltd. · 1993

https://510kreport.com/device/K780619 · printed Nov 6, 2026

Cite this page

510(k) Report. “K780619: Preformed Tooth Positioner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K780619

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