510(k) · Cleared
ClearedSilicone Carving Block
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hanson Medical, Inc. · MIB Elastomer, Silicone Block
Cleared on Nov 13, 1997 after a 44-day review. The FDA summary names its predicate without a number.
- Decided
- Nov 13, 1997
- Review
- 44 days
- Class
- Class II
- Product code
- MIB
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 MIB? 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 MIB device
- #1 K241150 MISTI Silicone Implantscore 8.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | — | Allied Biomedical Carving Block Named without a submission number | |
| * | — | Allied Biomedical Contour Carving Block Named without a submission number |
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.
How does its category compare?
All MIB devicesMIB Elastomer, Silicone Block: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MIB
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MIB
102in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MIB
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MIB
18in 2025
MAUDE reports naming product code MIB, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 10 |
| 2019 | 1 | — | 0 | 3 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 3 | 102 | 0 | 19 |
| 2023 | 1 | — | 0 | 74 |
| 2024 | 1 | — | 0 | 32 |
| 2025 | 0 | — | 3 | 18 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Silicone Carving Blocks are to be used for carving implants or bone onlays for various surgical uses by the surgeon. The contour carving blocks with curved surfaces lend themselves to carving chin implants and malar implants.
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/K973728 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973728: Silicone Carving Block.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973728
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026