510(k) · Cleared
ClearedA-Silicone for Bite Registration
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shandong Huge Dental Material Corporation · ELW Material, Impression
Cleared on Sep 24, 2020 as substantially equivalent to K024034 (Zhermack S.P.A., 2002) after a 94-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Sep 24, 2020
- Review
- 94 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K024034 (2002). No later device cites it as a predicate yet.
- Root · 1 generation backK024034 Occlufast RockZhermack S.P.A. · 2002
- This deviceK201684 A-Silicone for Bite RegistrationShandong Huge Dental Material Corporation · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K024034 | Occlufast Rock | Zhermack S.P.A. | 2002 | — |
| 0 (this device) | K201684 | A-Silicone for Bite Registration | Shandong Huge Dental Material Corporation | 2020 | — |
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 |
|---|---|---|---|
| * | K024034 | Occlufast RockSummary page 4…ation Owner/Operator Device Trade Name 510 (k) No. Product Code Predicate Zhermack S. P. A. Occlufast Rock K024034 ELW Primary This predicate have not been subject to a design-related recall. No reference devices were… | 2002 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K024034.
How does its category compare?
All ELW devicesELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
A-Silicone for Bite Registration is indicated for making occlusal registrations.
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/K201684 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201684: A-Silicone for Bite Registration.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201684
Report an extraction error
Are you the manufacturer?
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