# K191131: Solidence Multipockets

- Pathway: 510(k) (Traditional)
- Applicant: Solidence Surgical Corporation
- Decided: Aug 3, 2022 after 1,192 days
- Product code: FRG (Wrap, Sterilization)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K990567 (1999). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172280: BH Sterilization Pouch, Bh Medical Products Co., Ltd. (2018) Summary page 5.

## Indications for use
The Solidence Multipockets is a sterilization pouch intended to provide dentists with an effective method to enclose stainless steel dental burs of up to 0.5 grams intended for sterilization in steam autoclaves. The validated gravity steam sterilization cycle parameters are 10 minutes at 275 0 F (135 0 C), 30 minutes drying time, with a maximum weight of 18 grams, with no more than one bur in each pocket. The sterilization pockets maintain the sterility of the enclosed devices for one year post sterilization.

Source page: https://510kreport.com/device/K191131
Methodology: https://510kreport.com/methodology