# K943245: Spirit MB

- Pathway: 510(k) (Traditional)
- Applicant: Sybron Dental Specialties, Inc.
- Decided: Aug 23, 1994 after 48 days
- Product code: DYW (Bracket, Plastic, Orthodontic)
- Device class: 2
- Regulation: 21 CFR 872.5470
- Recalls of this device: 3 (0 Class I)
- 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Mar 25, 2014 · Class II · Z-1330-2014: Ormco Corporation initiated this recall of Spirit MB Brackets, Part Number 494-0110, Lot Number 081351013, because the ID dot, which designates the bracket as distal/gingival, is misplaced. The miside
- May 18, 2011 · Not classified · Z-0200-2012: Ormco Corporation is voluntarily recalling three lots of Spirit MB Brackets due to a manufacturing error.
- May 18, 2011 · Not classified · Z-0201-2012: Ormco Corporation is voluntarily recalling three lots of Spirit MB Brackets due to a manufacturing error.

Source page: https://510kreport.com/device/K943245
Methodology: https://510kreport.com/methodology