# K973728: Silicone Carving Block

- Pathway: 510(k) (Traditional)
- Applicant: Hanson Medical, Inc.
- Decided: Nov 13, 1997 after 44 days
- Product code: MIB (Elastomer, Silicone Block)
- Device class: 2
- Regulation: 21 CFR 874.3620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Allied Biomedical Carving Block: named in the summary without a submission number
- (no number) Allied Biomedical Contour Carving Block: named in the summary without a submission number

## Indications for use
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.

Source page: https://510kreport.com/device/K973728
Methodology: https://510kreport.com/methodology