Home › TP ORTHODONTICS INC › First Molar Comb Convert Rotation Tube
First Molar Comb Convert Rotation Tube
TP ORTHODONTICS INC · Model 391-271 · UDI-DI 00192029024331
8
510(k) clearances
25
Adverse events
4
Recalls
114
Facilities
Description
LR 1st Molar Auto Rot W/O Lip Bumper Reactivation Torque -27, Tip 0, Distal Offset 4 H.G. 0 0.46 mm x 0.64 mm (.018" x .025") 4.4 mm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-01-17 | Ormco/Sybronendo | The action is being taken due to an increase in complaints relating to the lower buccal tube slide doors not staying close. In the event of functional failure, broken/damage buccal |
| 2020-01-17 | Ormco/Sybronendo | The action is being taken due to an increase in complaints relating to the lower buccal tube slide doors not staying close. In the event of functional failure, broken/damage buccal |
| 2013-03-08 | Ormco/Sybronendo | Ormco Corporation is voluntarily recalling one (1) lot of Bracket Buccal Tubes as a result of a packaging error. More specifically, the Bracket Buccal Tubes product package correct |
| 2010-11-01 | Ortho Organizers Inc | Products were mis-labeled as nickel free. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.