Luna
Luna Opal MB Mini .018 Kit 5x5 U & L Hooks 3, 4, 5
1manufacturer
128catalogue numbers in this listing
1recall
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wuxi TP Orthodontics Material Co., Ltd. | Wuxi | Jiangsu | Repacker / relabeller | 9 |
Record
| Listed by | Ultradent Products Inc., United States |
|---|---|
| FDA product code | NJM |
| Device type | Bracket, Ceramic, Orthodontic |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5470 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Record published | 2016-09-22 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 221312 | In distribution | |
| 221122 | In distribution | |
| 221307 | In distribution | |
| 211307 | In distribution | |
| 221119 | In distribution | |
| 211121 | In distribution | |
| 211206 | In distribution | |
| 211102 | In distribution | |
| 211202 | In distribution | |
| 221403 | In distribution | |
| 211119 | In distribution | |
| 211117 | In distribution | |
| 211123 | In distribution | |
| 211204 | In distribution | |
| 211104 | In distribution | |
| 221116 | In distribution | |
| 221112 | In distribution | |
| 221107 | In distribution | |
| 221106 | In distribution | |
| 211309 | In distribution | |
| 221302 | In distribution | |
| 221313 | In distribution | |
| 211403 | In distribution | |
| 211306 | In distribution | |
| 211109 | In distribution | |
| 221310 | In distribution | |
| 221314 | In distribution | |
| 211201 | In distribution | |
| 221321 | In distribution | |
| 221322 | In distribution | |
| 221309 | In distribution | |
| 211405 | In distribution | |
| 211408 | In distribution | |
| 221203 | In distribution | |
| 221104 | In distribution | |
| 211203 | In distribution | |
| 221311 | In distribution | |
| 221409 | In distribution | |
| 211318 | In distribution | |
| 221303 | In distribution | |
| 211409 | In distribution | |
| 221123 | In distribution | |
| 221315 | In distribution | |
| 211113 | In distribution | |
| 211301 | In distribution | |
| 221401 | In distribution | |
| 221115 | In distribution | |
| 211120 | In distribution | |
| 221114 | In distribution | |
| 211404 | In distribution | |
| 211124 | In distribution | |
| 221117 | In distribution | |
| 221121 | In distribution | |
| 221113 | In distribution | |
| 221205 | In distribution | |
| 221316 | In distribution | |
| 221402 | In distribution | |
| 221406 | In distribution | |
| 221209 | In distribution | |
| 211207 | In distribution | |
| 211106 | In distribution | |
| 211105 | In distribution | |
| 211402 | In distribution | |
| 211118 | In distribution | |
| 221206 | In distribution | |
| 211313 | In distribution | |
| 221306 | In distribution | |
| 211107 | In distribution | |
| 221103 | In distribution | |
| 221102 | In distribution | |
| 211320 | In distribution | |
| 221305 | In distribution | |
| 221304 | In distribution | |
| 211308 | In distribution | |
| 211103 | In distribution | |
| 221201 | In distribution | |
| 211114 | In distribution | |
| 211305 | In distribution | |
| 211122 | In distribution | |
| 211311 | In distribution | |
| 211112 | In distribution | |
| 221111 | In distribution | |
| 211406 | In distribution | |
| 221109 | In distribution | |
| 211319 | In distribution | |
| 221319 | In distribution | |
| 221120 | In distribution | |
| 221301 | In distribution | |
| 221108 | In distribution | |
| 221118 | In distribution | |
| 221405 | In distribution | |
| 211101 | In distribution | |
| 211110 | In distribution | |
| 221105 | In distribution | |
| 211310 | In distribution | |
| 221204 | In distribution | |
| 211208 | In distribution | |
| 211321 | In distribution | |
| 221318 | In distribution | |
| 221202 | In distribution | |
| 211304 | In distribution | |
| 211209 | In distribution | |
| 211111 | In distribution | |
| 211205 | In distribution | |
| 211315 | In distribution | |
| 221407 | In distribution | |
| 211116 | In distribution | |
| 221101 | In distribution | |
| 211303 | In distribution | |
| 211108 | In distribution | |
| 221208 | In distribution | |
| 221404 | In distribution | |
| 211317 | In distribution | |
| 221110 | In distribution | |
| 221317 | In distribution | |
| 221124 | In distribution | |
| 211115 | In distribution | |
| 211407 | In distribution | |
| 211316 | In distribution | |
| 211322 | In distribution | |
| 211302 | In distribution | |
| 221320 | In distribution | |
| 211401 | In distribution | |
| 221308 | In distribution | |
| 211314 | In distribution | |
| 211312 | In distribution | |
| 221408 | In distribution | |
| 221207 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| QuicKlear® | Forestadent Bernhard Förster GmbH | 841 |
| Bracket, Ceramic, Orthodontic | Flexmedics | 600 |
| Experience | GC Orthodontics America Inc. | 500 |
| TruKlear | Forestadent Bernhard Förster GmbH | 401 |
| Chic | GC Orthodontics America Inc. | 348 |
| Bracket, Ceramic, Orthodontic | Forestadent Bernhard Förster GmbH | 342 |
| IN-Ovation® C | Dentsply Sirona Orthodontics Inc. | 327 |
| Intrigue | Lancer Orthodontics, Inc. | 253 |
| Empower Clear | American Orthodontics | 250 |
| Empower Clear Bracket | American Orthodontics | 250 |
| InVu Ceramic Brackets | TP Orthodontics, Inc. | 226 |
| RadiancePlus | American Orthodontics | 179 |
Showing 12 of 399. All products under Bracket, Ceramic, Orthodontic
Recalls
1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-11-19 | Class III | Process control | Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the design control process was not complete prior to distribution. | 217 units | 2014-10-06 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.