510(k) · Cleared
ClearedPekkton Ivory
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cendres & Metaux SA · EBG Crown And Bridge, Temporary, Resin
Cleared on Feb 21, 2013 as substantially equivalent to K093027 (Straumann USA, 2010) and 2 other predicates after an 87-day review. Its family tree reaches back 8 generations to 1990.
- Decided
- Feb 21, 2013
- Review
- 87 days
- Class
- Class II
- Product code
- EBG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K894844 (1990). 30 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 7 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 6 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 5 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- 4 generations backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- 3 generations backK062129 P.0004 ImplantsInstitut Straumann AG · 2006
- 2 generations backK070478 P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap)Straumann Manufacturing, Inc. · 2007
- 1 generation backK093027 Straumann RC Temporary AbutmentsStraumann USA · 2010
- This deviceK123638 Pekkton IvoryCendres & Metaux SA · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −7 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −6 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −5 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| −4 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| −3 | K062129 | P.0004 Implants | Institut Straumann AG | 2006 | — |
| −2 | K070478 | P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap) | Straumann Manufacturing, Inc. | 2007 | — |
| −1 | K093027 | Straumann RC Temporary Abutments | Straumann USA | 2010 | — |
| 0 (this device) | K123638 | Pekkton Ivory | Cendres & Metaux SA | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 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 EBG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EBG device
- #1 K253380 “FLNT Base” and “FLNT Temp”score 12.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K093027 | Straumann RC Temporary AbutmentsSummary page 1…which Equivalence is Claimed (Predicate Device) Predicate Devices: Straumann RC Temporary Telio® CAD KMD-Markl Tissue Marker AbutmentII K093027 IK093708 IK093473 Figure 1: Predicate Devices For details please refer to chap… | 2010 |
| * | K093708 | Telio CadSummary page 1…redicate Device) Predicate Devices: Straumann RC Temporary Telio® CAD KMD-Markl Tissue Marker AbutmentII K093027 IK093708 IK093473 Figure 1: Predicate Devices For details please refer to chapter "Comparison / Compatibility… | 2010 |
| * | K093473 | KMD-MARK1 Tissue MarkerSummary page 1…traumann RC Temporary Telio® CAD KMD-Markl Tissue Marker AbutmentII K093027 IK093708 IK093473 Figure 1: Predicate Devices For details please refer to chapter "Comparison / Compatibility; Substantially Equivalence". Descri… | 2010 |
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 23 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 30 ancestors has a recall of any class.
- 4 other devices also cite its predicate K093027.
How does its category compare?
All EBG devicesEBG Crown And Bridge, Temporary, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · EBG
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBG
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBG
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBG
1in 2025
MAUDE reports naming product code EBG, 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 | 3 | 64 | 0 | 4 |
| 2008 | 9 | 83 | 0 | 4 |
| 2009 | 2 | — | 1 | 1 |
| 2010 | 5 | 103 | 0 | 1 |
| 2011 | 10 | 96 | 0 | 1 |
| 2012 | 5 | 90 | 0 | 5 |
| 2013 | 2 | — | 0 | 11 |
| 2014 | 3 | 114 | 0 | 23 |
| 2015 | 6 | 209 | 0 | 26 |
| 2016 | 4 | 163 | 0 | 8 |
| 2017 | 2 | — | 0 | 4 |
| 2018 | 4 | 202 | 0 | 0 |
| 2019 | 6 | 98 | 0 | 6 |
| 2020 | 14 | 194 | 1 | 2 |
| 2021 | 3 | 265 | 0 | 4 |
| 2022 | 3 | 73 | 0 | 2 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 5 | 144 | 0 | 0 |
| 2025 | 4 | 106 | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Pekkton® ivory is intended to be used for long-term, temporary dental crowns and bridges frameworks.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123638 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123638: Pekkton Ivory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123638
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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