Zenith™ Standard Edge Ceramic Brackets
ZENITH™ STD EDGE CRMC UP 5-5/LW 3-3 022 KIT Zenith™ Series Ceramic [CR] aesthetic brackets are precision designed and manufactured so that no special treatment mechanics or bonding…
ZENITH™ STD EDGE CRMC UP 5-5/LW 3-3 022 KIT Zenith™ Series Ceramic [CR] aesthetic brackets are precision designed and manufactured so that no special treatment mechanics or bonding procedures are necessary. All of the same clinical techniques routinely used with metal brackets are applicable with Zenith™. Zenith™ brackets are designed with all the features needed to achieve contemporary treatment objectives including rounded contours for comfort and reduced friction, sweeping tie wing undercuts, notched bases for mechanical bonds, plus many more.
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 | G & H Wire Company, United States |
|---|---|
| FDA product code | NJM |
| Device type | Bracket, Ceramic, Orthodontic |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5470 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K132368 |
| Record published | 2016-09-24 |
| Record revised | 2023-01-31 (version 4) |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| EDCRU122A-V | 5 | In distribution | |
| EDCRU218A-V | 5 | In distribution | |
| EDCRU422A-V | 5 | In distribution | |
| EDCRU222A-V | 5 | In distribution | |
| KTECR225533PA | In distribution | ||
| KTECR185533A | In distribution | ||
| KTEDCR1855PA | In distribution | ||
| EDCRU318A-V | 5 | In distribution | |
| KTEDCR2255A | In distribution | ||
| EDCRL118A-V | 5 | In distribution | |
| KTEDCR2255PA | In distribution | ||
| EDCRU118A-V | 5 | In distribution | |
| EDCRU418A-V | 5 | In distribution | |
| EDCRU322A-V | 5 | In distribution | |
| KTEDCR1855A | In distribution | ||
| EDCRL122A-V | 5 | 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
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.