# K082974: Mystique MB Ceramic Brackets

- Pathway: 510(k) (Special)
- Applicant: Dentsply Interntional
- Decided: Nov 7, 2008 after 32 days
- Product code: NJM (Bracket, Ceramic, Orthodontic)
- Device class: 2
- Regulation: 21 CFR 872.5470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K852179 (1985). 2 ancestors in all.
23 later devices descend from it; 4 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042178: Orthodontic Ceramic Brackets, Dentsply Intl. (2004) Summary page 1.

## Most influential descendants
- K102803: Clarity Advanced Ceramic Brackets (2011), 15 descendants of its own
- K123094: Orthodontic Ceramic Brackets (2012), 7 descendants of its own
- K160615: Orthodontic Ceramic Brackets 1.1 (2016), 6 descendants of its own
- K090454: Allure MB Ceramic Brackets (2009), 5 descendants of its own
- K181271: Signature Orthodontic System (2018), 4 descendants of its own

## Indications for use
Indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.

Source page: https://510kreport.com/device/K082974
Methodology: https://510kreport.com/methodology