510(k) · Cleared
ClearedSR Vivodent S, SR Orthotyp S, SR Ortholingual S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivoclar Vivadent, Inc. · ELM Denture, Plastic, Teeth
Cleared on Jan 14, 2014 as substantially equivalent to K844349 (Ivoclar USA, Inc., 1984) and 1 other predicate after a 112-day review. Its family tree reaches back 1 generation to 1984.
- Decided
- Jan 14, 2014
- Review
- 112 days
- Class
- Class II
- Product code
- ELM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K844349 (1984). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK844349 SR Vivodent PE Anterior Teeth & SR Orthotyp RE PosIvoclar USA, Inc. · 1984
- This deviceK132984 SR Vivodent S, SR Orthotyp S, SR Ortholingual SIvoclar Vivadent, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K844349 | SR Vivodent PE Anterior Teeth & SR Orthotyp RE Pos | Ivoclar USA, Inc. | 1984 | — |
| 0 (this device) | K132984 | SR Vivodent S, SR Orthotyp S, SR Ortholingual S | Ivoclar Vivadent, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K844349 | SR Vivodent PE Anterior Teeth & SR Orthotyp RE PosSummary page 1…SIR Vivodent S, SIR Orthotyp S, SIR Ortholingual S Classification Name: Denture, Plastic, Teeth (872.3590) Predicate Devices: SIR Vivodent PE, SIR Orthotyp PE (K844349) and Phonares It(K120736) Device Description: Preformed denture teeth used for total and partial dentures and implant- supported… | 1984 |
| * | K120736 | SR Phonares IISummary page 1…Orthotyp S, SIR Ortholingual S Classification Name: Denture, Plastic, Teeth (872.3590) Predicate Devices: SIR Vivodent PE, SIR Orthotyp PE (K844349) and Phonares It(K120736) Device Description: Preformed denture teeth used for total and partial dentures and implant- supported removable prostheses. T… | 2012 |
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.
What does this lineage say?
- None of the 2 ancestors has a recall.
How does its category compare?
All ELM devicesELM Denture, Plastic, Teeth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · ELM
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · ELM
82in 2012
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
MAUDE reports naming product code ELM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 125 | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 5 | 82 | 0 | 4 |
| 2013 | 2 | — | 0 | 43 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Preformed denture teeth used for total and partial dentures and implant-supported removable prostheses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132984 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132984: SR Vivodent S, SR Orthotyp S, SR Ortholingual S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132984
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026