APC™ Plus Clarity™ Advanced
Clarity(TM) ADVANCED Ceramic Bracket APC(TM) PLUS MBT(TM) L1,2 -6T/0A .022 5/Pk
1manufacturer
129catalogue numbers in this listing
2510(k) clearances naming this product code
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 | 3M Unitek, United States |
|---|---|
| FDA product code | NJM |
| Device type | Bracket, Ceramic, Orthodontic |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5470 |
| Record published | 2016-09-24 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 5006-264 | 5 | In distribution | |
| 5006-221 | 5 | In distribution | |
| 5006-279 | 5 | In distribution | |
| 5006-350 | 5 | In distribution | |
| 5006-312 | 5 | In distribution | |
| 5006-330 | 5 | In distribution | |
| 5006-371 | 5 | In distribution | |
| 5006-372 | 5 | In distribution | |
| 5006-108 | In distribution | ||
| 5006-317 | 5 | In distribution | |
| 5006-368 | 5 | In distribution | |
| 5006-308 | 5 | In distribution | |
| 5006-126 | In distribution | ||
| 5006-224 | 5 | In distribution | |
| 5006-136 | In distribution | ||
| 5006-213 | 5 | In distribution | |
| 5006-362 | 5 | In distribution | |
| 5006-259 | 5 | In distribution | |
| 5006-102 | In distribution | ||
| 5006-318 | 5 | In distribution | |
| 5006-216 | 5 | In distribution | |
| 5006-316 | 5 | In distribution | |
| 5006-135 | In distribution | ||
| 5006-119 | In distribution | ||
| 5006-112 | In distribution | ||
| 5006-255 | 5 | In distribution | |
| 5006-156 | In distribution | ||
| 5006-310 | 5 | In distribution | |
| 5006-125 | In distribution | ||
| 5006-357 | 5 | In distribution | |
| 5006-115 | In distribution | ||
| 5006-376 | 5 | In distribution | |
| 5006-113 | In distribution | ||
| 5006-356 | 5 | In distribution | |
| 5006-355 | 5 | In distribution | |
| 5006-275 | 5 | In distribution | |
| 5006-105 | In distribution | ||
| 5006-315 | 5 | In distribution | |
| 5006-329 | 5 | In distribution | |
| 5006-103 | In distribution | ||
| 5006-153 | In distribution | ||
| 5006-302 | 5 | In distribution | |
| 5006-202 | 5 | In distribution | |
| 5006-116 | In distribution | ||
| 5006-109 | In distribution | ||
| 5006-352 | 5 | In distribution | |
| 5006-262 | 5 | In distribution | |
| 5006-324 | 5 | In distribution | |
| 5006-128 | In distribution | ||
| 5006-208 | 5 | In distribution | |
| 5006-380 | 5 | In distribution | |
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| 5006-201 | 5 | In distribution | |
| 5006-267 | 5 | In distribution | |
| 5006-257 | 5 | In distribution | |
| 5006-145 | In distribution | ||
| 5006-158 | In distribution | ||
| 5006-256 | 5 | In distribution | |
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| 5006-143 | In distribution | ||
| 5006-261 | 5 | In distribution | |
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| 5006-251 | 5 | In distribution | |
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| 5006-326 | 5 | In distribution | |
| 5006-252 | 5 | In distribution | |
| 5006-155 | In distribution | ||
| 5006-123 | In distribution | ||
| 5006-212 | 5 | In distribution | |
| 5006-354 | 5 | In distribution | |
| 5006-280 | 5 | In distribution | |
| 5006-250 | 5 | In distribution | |
| 5006-305 | 5 | In distribution | |
| 5006-360 | 5 | In distribution | |
| 5006-223 | 5 | In distribution | |
| 5006-226 | 5 | In distribution | |
| 5006-260 | 5 | In distribution | |
| 5006-307 | 5 | In distribution | |
| 5006-205 | 5 | In distribution | |
| 5006-323 | 5 | In distribution | |
| 5006-379 | 5 | In distribution | |
| 5006-118 | In distribution | ||
| 5006-253 | 5 | In distribution | |
| 5006-351 | 5 | In distribution | |
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| 5006-353 | 5 | In distribution | |
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| 5006-359 | 5 | In distribution | |
| 5006-148 | In distribution | ||
| 5006-222 | 5 | In distribution | |
| 5006-121 | In distribution | ||
| 5006-206 | 5 | In distribution | |
| 5006-110 | In distribution | ||
| 5006-100 | In distribution | ||
| 5006-229 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K102803 | 2011-02-17 |
| K062305 | 2006-10-18 |
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.