510(k) · Cleared
ClearedIdentium Heavy, Identium Medium, Identium Scan Heavy, Identium Scan Medium, Identium Scan Light
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kettenbach GmbH & Co. KG · ELW Material, Impression
Cleared on Nov 14, 2011 as substantially equivalent to K092867 (Kettenbach GmbH & Co. KG, 2009) and 2 other predicates after a 7-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Nov 14, 2011
- Review
- 7 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K943574 (1994). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK943574 Capture Impression MaterialDentsply Intl. · 1994
- 5 generations backK973782 Aquasil XLV Smart Wetting Impression MaterialDentsply Intl. · 1997
- 4 generations backK021410 Aquasil Ultra XLV Smart Wetting Impression MaterialDentsply Intl. · 2002
- 3 generations backK082560 Panasil Impression Materials, Including Putty, Binetics, Tray…Kettenbach GmbH & Co. KG · 2008
- 2 generations backK083701 Panasil Initial Contact and Panasil TrayKettenbach GmbH & Co. KG · 2009
- 1 generation backK092867 Identium Heavy, Medium, Medium Soft, LightKettenbach GmbH & Co. KG · 2009
- This deviceK113279 Identium Heavy, Identium Medium, Identium Scan Heavy, Identium Scan…Kettenbach GmbH & Co. KG · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K943574 | Capture Impression Material | Dentsply Intl. | 1994 | — |
| −5 | K973782 | Aquasil XLV Smart Wetting Impression Material | Dentsply Intl. | 1997 | — |
| −4 | K021410 | Aquasil Ultra XLV Smart Wetting Impression Material | Dentsply Intl. | 2002 | — |
| −3 | K082560 | Panasil Impression Materials, Including Putty, Binetics, Tray, Monophase and… | Kettenbach GmbH & Co. KG | 2008 | — |
| −2 | K083701 | Panasil Initial Contact and Panasil Tray | Kettenbach GmbH & Co. KG | 2009 | — |
| −1 | K092867 | Identium Heavy, Medium, Medium Soft, Light | Kettenbach GmbH & Co. KG | 2009 | — |
| 0 (this device) | K113279 | Identium Heavy, Identium Medium, Identium Scan Heavy, Identium Scan Medium… | Kettenbach GmbH & Co. KG | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2008 | 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 ELW? 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 ELW device
- #1 K254152 Dia-X Sil Light Bodyscore 14.1 · 8 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 |
|---|---|---|---|
| * | K092867 | Identium Heavy, Medium, Medium Soft, LightSummary page 2…emnarket Notification [510(k)] Ideatium® Impression Materials C. Predicate Devices Trade Name: " Went/urn® Impression Materials (1<092867) including: identium@® Heavy (regular and fast set in 1:5 foil… | 2009 |
| * | K082560 | Panasil Impression Materials, Including Putty, Binetics, Tray, Monophase and ContactSummary page 2…dentium® Light (regular and fast set in 1:5 foil bag system) * Panasil®monophase (regular, 1:1 cartidge) - (1<082560) * Futar®Scan (1:1 cartridge) - (K081 120) D. Device Description Identium® Impression Materi… | 2008 |
| * | K081120 | Futar (Futar, Futar D, Futar D Fast, Futar D Slow, Futar Scan Bite Registration MaterialsSummary page 2…bag system) * Panasil®monophase (regular, 1:1 cartidge) - (1<082560) * Futar®Scan (1:1 cartridge) - (K081 120) D. Device Description Identium® Impression Materials are addition-curing, elastomeric materials. Identium® I… | 2008 |
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 17 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 15 ancestors has a recall of any class.
How does its category compare?
All ELW devicesELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · ELW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ELW
98in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ELW
3in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ELW
22in 2025
MAUDE reports naming product code ELW, 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 | 7 | 60 | 0 | 9 |
| 2008 | 11 | 30 | 0 | 17 |
| 2009 | 7 | 43 | 0 | 7 |
| 2010 | 5 | 88 | 1 | 16 |
| 2011 | 9 | 83 | 0 | 15 |
| 2012 | 7 | 87 | 1 | 14 |
| 2013 | 5 | 67 | 3 | 32 |
| 2014 | 11 | 122 | 0 | 35 |
| 2015 | 8 | 93 | 0 | 18 |
| 2016 | 7 | 166 | 3 | 15 |
| 2017 | 3 | 89 | 0 | 17 |
| 2018 | 5 | 126 | 0 | 14 |
| 2019 | 2 | — | 0 | 24 |
| 2020 | 4 | 99 | 0 | 8 |
| 2021 | 3 | 76 | 0 | 6 |
| 2022 | 7 | 60 | 0 | 9 |
| 2023 | 2 | — | 0 | 13 |
| 2024 | 3 | 98 | 0 | 3 |
| 2025 | 2 | — | 0 | 22 |
| 2026 | 3 | 268 | 0 | — |
What is it indicated for?
Identium® Heavy (regular 1:1, fast 1:1) is to be used as a heavy-bodied impression material in one-step technique (double mix) for: * Impressions for crowns/bridges, inlays/onlays and veneer preparations * Functional impressions * Impressions for full or partial dentures * Implant impressions Identium® Medium (regular 1:1, fast 1:1) is to be used as a medium-bodied tray or syringeable impression material in one-step technique (monophase or double mix)…
Read the full statement (207 words)
Identium® Heavy (regular 1:1, fast 1:1) is to be used as a heavy-bodied impression material in one-step technique (double mix) for:
* Impressions for crowns/bridges, inlays/onlays and veneer preparations
* Functional impressions
* Impressions for full or partial dentures
* Implant impressions
Identium® Medium (regular 1:1, fast 1:1) is to be used as a medium-bodied tray or syringeable impression material in one-step technique (monophase or double mix) for:
* Impressions for crowns/bridges, inlays/onlays and veneer preparations
* Functional impressions
* Fixation impressions
* Implant impressions
Identium® Scan Heavy (regular 1:5) is to be used as a heavy-bodied impression material in one-step technique (double mix) for:
* Impressions for crowns/bridges, inlays/onlays and veneer preparations
* Functional impressions
* Impressions for full or partial dentures
* Implant impressions
Identium® Scan Medium (regular 1:5) is to be used as a medium-bodied tray or syringeable impression material in one-step technique (monophase or double mix) for:
* Impressions for crowns/bridges, inlays/onlays and veneer preparations
* Functional impressions
* Fixation impressions
* Implant impressions
Identium® Scan Light (regular 1:1) is to be used as a syringeable light-bodied impression material in one-step technique (double mix) for:
* Impressions for crowns/bridges, inlays/onlays and veneer preparations
* Reline impressions
* Impressions for full or partial dentures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113279 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113279: Identium Heavy, Identium Medium, Identium Scan Heavy, Identium Scan Medium, Identium Scan Light.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113279
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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