510(k) · Cleared
ClearedRapid HB, Rapid LB, Rapid MB
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Deutschland GmbH · ELW Material, Impression
Cleared on Oct 31, 2017 as substantially equivalent to K032001 (3M Espe AG Dental Products, 2003) after an 11-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Oct 31, 2017
- Review
- 11 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K954192 (1995). 8 ancestors in all, the oldest K953027 (1995). No later device cites it as a predicate yet.
- Root · 4 generations backK954192 Impregum PentaEspe GmbH & Co. Kg. · 1995
- 3 generations backK992897 Impregum PentaEspe Dental AG · 1999
- 2 generations backK994192 Impregum Penta M MonosoftEspe Dental AG · 2000
- 1 generation backK032001 Poly Q (Garant L, Penta M, Penta H)3M Espe AG Dental Products · 2003
- This deviceK173318 Rapid HB, Rapid LB, Rapid MB3M Deutschland GmbH · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954192 | Impregum Penta | Espe GmbH & Co. Kg. | 1995 | — |
| −3 | K992897 | Impregum Penta | Espe Dental AG | 1999 | — |
| −2 | K994192 | Impregum Penta M Monosoft | Espe Dental AG | 2000 | — |
| −1 | K032001 | Poly Q (Garant L, Penta M, Penta H) | 3M Espe AG Dental Products | 2003 | — |
| 0 (this device) | K173318 | Rapid HB, Rapid LB, Rapid MB | 3M Deutschland GmbH | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 2000 | 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? (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 |
|---|---|---|---|
| * | K032001 | Poly Q (Garant L, Penta M, Penta H)Summary page 5…product code ELW) Device Class: .......................... Class II Predicate Devices .................... Impregum Penta Soft Quick Step HB (K032001) ................................................. Impregum Penta Soft Quick Step MB (K032001) ........… | 2003 |
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 4 companies; a new generation was cleared every 3.8 years on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K032001.
How does its category compare?
All ELW devicesELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
Impressions of inlay, onlay, veneer, crown, and bridge preparations
Fixation and implant impressions
RAPID HB, MB and LB are especially suitable for taking impressions of single-unit and double-unit preparations.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K173318 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173318: Rapid HB, Rapid LB, Rapid MB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173318
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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