# K132953: Tidisheild

- Pathway: 510(k) (Traditional)
- Applicant: Tidi Products,Llc
- Decided: Feb 18, 2014 after 151 days
- Product code: PEM (Dental Barriers And Sleeves)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K151123: Pac-Dent Barrier Sleeve, Cover-It (TM) Barrier Film (2016), 9 descendants of its own
- K190484: BH Medical Dental Barrier Sleeves and Barrier Film (2019), 4 descendants of its own
- K160232: Disposable Barrier Sleeves and Covers (2016), 3 descendants of its own
- K233918: Dental Barrier and Sleeves (2024), 2 descendants of its own
- K250606: Dental Barrier and Sleeves (2025), 1 descendant of its own

## Indications for use
The TIDiShield Curing Light Sleeves are indicated for use as a barrier that is used as an accessory to dental instrument. These sleeves are non-sterile and are intended for single patient use only.

Source page: https://510kreport.com/device/K132953
Methodology: https://510kreport.com/methodology