NQSClass I
Bracket, Metal, Orthodontic, Reprocessed
Dental · 21 CFR 872.5410
Intended for use in orthodontic treatment. The device is affixed to a tooth so that pressure can be exerted on the teeth. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
MDR events2All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances0All time
Recent MDR events
2 adverse event reports on file
Event type breakdown
Injury2
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.