510(k) · Cleared
ClearedTigran Peribrush
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tigran Technologies AB · ELB Scaler, Rotary
Cleared on Sep 17, 2012 as substantially equivalent to K111724 (Straumann USA, 2011) after a 158-day review. Its family tree reaches back 4 generations to 1990.
- Decided
- Sep 17, 2012
- Review
- 158 days
- Class
- Class II
- Product code
- ELB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K900709 (1990). 5 ancestors in all, the oldest K782007 (1979). No later device cites it as a predicate yet.
- Root · 4 generations backK900709 Air Flow SiiElectro Medical Systems (Ems Sa) · 1990
- 3 generations backK073284 Air-Flow Master Standard(Ems Sa) Electro Medical Systems · 2007
- 2 generations backK082791 Ems Air-Flow MasterE.M.S Electro Medical Systems S.A · 2009
- 1 generation backK111724 Straumann TibrushStraumann USA · 2011
- This deviceK121114 Tigran PeribrushTigran Technologies AB · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K900709 | Air Flow Sii | Electro Medical Systems (Ems Sa) | 1990 | — |
| −3 | K073284 | Air-Flow Master Standard | (Ems Sa) Electro Medical Systems | 2007 | — |
| −2 | K082791 | Ems Air-Flow Master | E.M.S Electro Medical Systems S.A | 2009 | — |
| −1 | K111724 | Straumann Tibrush | Straumann USA | 2011 | — |
| 0 (this device) | K121114 | Tigran Peribrush | Tigran Technologies AB | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 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 ELB? 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? (1)
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 |
|---|---|---|---|
| * | K111724 | Straumann TibrushSummary page 2…gran m Per iBrush T M -fI( 6. SUBSTANTIAL EQUIVALENCE In summary, Tigran' PeriBrushN, is substantially equivalent to the cited predicate device, Straumann* TiBrush, K111724. They have the same intended use designed for mechanical debridement of dental titanium implant surfaces to remove plaque and cal… | 2011 |
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?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All ELB devicesELB Scaler, Rotary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · ELB
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · ELB
Too few ELB 510(k)s in any year since 2007 to give a median.
Recalls per year · ELB
No recall names ELB since 2007.
Adverse event reports per year · ELB
No MAUDE report names ELB since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Tigran TM PeriBrush TM is a debridement instrument for titanium dental implants subjected to peri-implantitis. It is indicated for the open debridement of titanium Implant surfaces in bone defects caused by peri-implantitis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121114 · printed Nov 5, 2026
Cite this page
510(k) Report. “K121114: Tigran Peribrush.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121114
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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