510(k) · Cleared
ClearedPanasil Initial Contact and Panasil Tray
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 Jan 9, 2009 as substantially equivalent to K082560 (Kettenbach GmbH & Co. KG, 2008) after a 25-day review. Its family tree reaches back 4 generations to 1994. 2 later devices descend from it.
- Decided
- Jan 9, 2009
- Review
- 25 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K943574 (1994). 8 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK943574 Capture Impression MaterialDentsply Intl. · 1994
- 3 generations backK973782 Aquasil XLV Smart Wetting Impression MaterialDentsply Intl. · 1997
- 2 generations backK021410 Aquasil Ultra XLV Smart Wetting Impression MaterialDentsply Intl. · 2002
- 1 generation backK082560 Panasil Impression Materials, Including Putty, Binetics, Tray…Kettenbach GmbH & Co. KG · 2008
- This deviceK083701 Panasil Initial Contact and Panasil TrayKettenbach GmbH & Co. KG · 2009
- Descendant · cites it directly · 1 of its ownK092867 Identium Heavy, Medium, Medium Soft, LightKettenbach GmbH & Co. KG · 2009
- Descendant · 2 generations on · 0 of its ownK113279 Identium Heavy, Identium Medium, Identium Scan Heavy, Identium Scan…Kettenbach GmbH & Co. KG · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K943574 | Capture Impression Material | Dentsply Intl. | 1994 | — |
| −3 | K973782 | Aquasil XLV Smart Wetting Impression Material | Dentsply Intl. | 1997 | — |
| −2 | K021410 | Aquasil Ultra XLV Smart Wetting Impression Material | Dentsply Intl. | 2002 | — |
| −1 | K082560 | Panasil Impression Materials, Including Putty, Binetics, Tray, Monophase and… | Kettenbach GmbH & Co. KG | 2008 | — |
| 0 (this device) | 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 | — |
| +2 | 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 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 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? (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 |
|---|---|---|---|
| * | K082560 | Panasil Impression Materials, Including Putty, Binetics, Tray, Monophase and ContactSummary page 1…ssion (21 CFR 872.3660, Product Code: ELW) C. Predicate Devices Trade Name: Panasil® Impression Materials (K082560)' D. Device Description Panasil®Impression Materials are addition-curing, elastomeric materials with hydrophilic propertie… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092867 | Identium Heavy, Medium, Medium Soft, Light | 2009 | 1 |
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 15 years and passes through 2 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K092867 (Kettenbach GmbH & Co. KG, 2009) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K082560.
How does its category compare?
All ELW devicesELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Panasilinitial contact (regular, regular fast, light, light fast, x-light, x-light fast) is to be used as a syringeable impression material for:
Two-step putty-wash impression technique.
One-step putty-wash impression technique.
One-step impression technique using a foil (plastic putty spacer).
One-step impression technique (simultaneous technique) using dual viscosities.
Reline impressions.
Fabricating full or partial dentures.
Panasiltray (fast 1:1, soft fast 5:1, soft fast 1:1) is to be used as a heavy-bodied material for:
one-step impression technique (simultaneous technique) using single or dual viscosities.
Two-step impression technique using dual viscosities.
Functional impressions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083701 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083701: Panasil Initial Contact and Panasil Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083701
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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