510(k) Report

510(k) · Cleared

Cleared

SR Antaris Anterior Teeth/SR Postaris Posterior Teeth

K962456510(k) TraditionalCleared Aug 6, 199642-day reviewClass II21 CFR 872.3590

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

Ivoclar North America, Inc. · ELM Denture, Plastic, Teeth

Cleared on Aug 6, 1996 after a 42-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Aug 6, 1996
Review
42 days
Class
Class II
Product code
ELM
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared1995200020052010201520202025
  1. This deviceK962456 SR Antaris Anterior Teeth/SR Postaris Posterior TeethIvoclar North America, Inc. · 1996
  2. Descendant · cites it directly · 0 of its ownK101064 Bredent Novo.Lign a/ Bredent Novo.Lign PBredent GmbH & Co. KG · 2010

Most influential descendants

Showing 1 of 1 · See all
  • K101064Bredent Novo.Lign a/ Bredent Novo.Lign PBredent GmbH & Co. KG · 2010 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K962456SR Antaris Anterior Teeth/SR Postaris Posterior TeethIvoclar North America, Inc.1996—
+1K101064Bredent Novo.Lign a/ Bredent Novo.Lign PBredent GmbH & Co. KG2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
FIG. 1 — Lineage of K962456, 1996–2010Source: 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 ELM? 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? (1)

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

NumberDeviceApplicantDecidedDescendants
K101064Bredent Novo.Lign a/ Bredent Novo.Lign PBredent GmbH & Co. KG20100

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, K101064 (Bredent GmbH & Co. KG, 2010) has gone furthest, with 0 descendants of its own.

How does its category compare?

All ELM devices

ELM Denture, Plastic, Teeth: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ELM

1in 2014

2007: 12009: 12010: 32012: 52013: 22014: 1
2007high 5 (2012) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ELM

82in 2012

2010: 125 days median2012: 82 days median
2007high 125 (2010) · low 82 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · ELM

No recall names ELM since 2007.

Adverse event reports per year · ELM

1in 2025

2008: 12012: 42013: 432017: 12018: 12020: 12025: 1
2007high 43 (2013) · low 0 (2007)2025

MAUDE reports naming product code ELM, 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
20071—00
20080—01
20091—00
2010312500
20110—00
201258204
20132—043
20141—00
20150—00
20160—00
20170—01
20180—01
20190—00
20200—01
20210—00
20220—00
20230—00
20240—00
20250—01
20260—0—

More from Ivoclar North America, Inc.

131 FDA decisions under this applicant name. See the company

  • K012174Eris Layering MaterialsIvoclar North America, Inc. · 20011 recall
  • K011491Helioseal Clear ChromaIvoclar North America, Inc. · 2001
  • K011492IN Ten-SIvoclar North America, Inc. · 2001
  • K011490Modification to ExciteIvoclar North America, Inc. · 2001
  • K011023D.SIGN 96Ivoclar North America, Inc. · 2001

Recent decisions in ELM

The ELM category page

  • K132984SR Vivodent S, SR Orthotyp S, SR Ortholingual SIvoclar Vivadent, Inc. · 2014
  • K122955Dentavit, Monarch, Acrotone, Senator, DentoriumWright Health Group, Ltd. · 2013
  • K122925New Stetic Artificial TeethNew Stetic · 2013
  • K122852Physiostar NFCCandulor USA, Inc. · 2012
  • K121749VeraciaShofu Dental Corporation · 2012

https://510kreport.com/device/K962456 · printed Nov 5, 2026

Cite this page

510(k) Report. “K962456: SR Antaris Anterior Teeth/SR Postaris Posterior Teeth.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962456

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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