510(k) · Cleared
ClearedSuflex Putty, Suflex Heavy, Suflex Mono, Suflex Light
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osstem Germany GmbH · ELW Material, Impression
Cleared on Mar 7, 2014 as substantially equivalent to K082560 (Kettenbach GmbH & Co. KG, 2008) and 4 other predicates after a 112-day review. Its family tree reaches back 4 generations to 1994. 12 later devices descend from it.
- Decided
- Mar 7, 2014
- Review
- 112 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K943574 (1994). 8 ancestors in all. 12 later devices descend from it, 2 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 deviceK133527 Suflex Putty, Suflex Heavy, Suflex Mono, Suflex LightOsstem Germany GmbH · 2014
- Descendant · cites it directly · 11 of its ownK151262 Hyflex Heavy, Hyflex Mono, Hyflex LightOsstem Implant Co., Ltd. · 2015
- Descendant · cites it directly · 10 of its ownK170736 HySil Impression MaterialsOsstem Implant Co., Ltd. · 2017
- Descendant · 2 generations on · 2 of its ownK214086 Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy…Genoss Co., Ltd. · 2022
- Descendant · 2 generations on · 2 of its ownK192941 HySil Super Fast Impression MaterialsOsstem Implant Co., Ltd. · 2020
- Descendant · 2 generations on · 1 of its ownK181236 HySil Impression MaterialsOsstem Implant Co., Ltd. · 2018
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K151262Hyflex Heavy, Hyflex Mono, Hyflex LightOsstem Implant Co., Ltd. · 2015 · cites it directly11descendants
- K170736HySil Impression MaterialsOsstem Implant Co., Ltd. · 2017 · cites it directly10descendants
- K214086Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite…Genoss Co., Ltd. · 2022 · 2 generations on2descendants
- K192941HySil Super Fast Impression MaterialsOsstem Implant Co., Ltd. · 2020 · 2 generations on2descendants
- K181236HySil Impression MaterialsOsstem Implant Co., Ltd. · 2018 · 2 generations on1descendant
View 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) | K133527 | Suflex Putty, Suflex Heavy, Suflex Mono, Suflex Light | Osstem Germany GmbH | 2014 | — |
| +1 | K151262 | Hyflex Heavy, Hyflex Mono, Hyflex Light | Osstem Implant Co., Ltd. | 2015 | — |
| +1 | K170736 | HySil Impression Materials | Osstem Implant Co., Ltd. | 2017 | — |
| +2 | K214086 | Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright… | Genoss Co., Ltd. | 2022 | — |
| +2 | K192941 | HySil Super Fast Impression Materials | Osstem Implant Co., Ltd. | 2020 | — |
| +2 | K181236 | HySil Impression Materials | Osstem Implant Co., Ltd. | 2018 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 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? (5)
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…Class 11I ELW 3. Predicate Device: Trade Name: Panasil Impression Materials (K082 560) Trade Name: Panasil Impression Materials (K95 42 82) Trade Name: Aquasil… | 2008 |
| * | K954281 | Panasil Impression Material Our reading of the summary gave K954282, FDA’s number for Ultracuff Blood Pressure Cuff and Inflation Bag (Statcorp, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Panasil Impression Materials”. | 1996 |
| * | K021413 | Aquasil Ultra Rigid Smart Wetting Impression MaterialSummary page 1…Impression Materials (K95 42 82) Trade Name: Aquasil Ultra Rigid Smart Wetting Impression Material (K(021413) Trade Name: Aquasil Ultra XLV Smart Wetting Impression Mater… | 2002 |
| * | K021410 | Aquasil Ultra XLV Smart Wetting Impression MaterialSummary page 1…Material (K(021413) Trade Name: Aquasil Ultra XLV Smart Wetting Impression Material (K(021410) Trade Name: Kerr VPS Impression Material(K050604)… | 2002 |
| * | K050604 | Kerr VPS Impression MaterialSummary page 1…uasil Ultra XLV Smart Wetting Impression Material (K(021410) Trade Name: Kerr VPS Impression Material(K050604) 113 Osstem German… | 2005 |
What descends from it? (12)
See all 122 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 20 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K151262 (Osstem Implant Co., Ltd., 2015) has gone furthest, with 11 descendants 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. 2014, 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?
Suflex Putty is to be used as panasil putty material for: - Two step putty impression technique - One step putty impression technique - Two step putty impression technique using a foil(plastic putty spacer) - One step putty impression technique for forming functional peripheries. Suflex Heavy is to be used a s panasil tray material for; - One step impression technique using single or dual viscosities. - Two step impression technique using dual…
Read the full statement (195 words)
Suflex Putty is to be used as panasil putty material for:
- Two step putty impression technique
- One step putty impression technique
- Two step putty impression technique using a foil(plastic putty spacer)
- One step putty impression technique for forming functional peripheries.
Suflex Heavy is to be used a s panasil tray material for;
- One step impression technique using single or dual viscosities.
- Two step impression technique using dual viscosities
- Functional impressions.
Suflex Mono is to be used as panasil monophase material for,
- Taking impression over fixed/removable restorations and implants
(transerring impression posts and bridge components)
- Functional impressions.
- Fabricating crown and bridgework or inlays.
- Fabricating ill or partial dentures.
- Reline impressions.
- Use in the simultaneous mixing technique as well as the putty
- Transferring root posts when fabricating posts and cores indirectly.
Suflex Light is to be used as panasil contact material for
- Two step putty impression technique.
- One step putty impression technique.
- One step impression technique using a foil(plastic putty spacer)
- One step impression technique (simultaneous technique) using dual viscosities.
- Reline impressions.
- Fabricating fill or partial denture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133527 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133527: Suflex Putty, Suflex Heavy, Suflex Mono, Suflex Light.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133527
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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