Empower Clear
Empower Clear is a family of single-use ceramic orthodontic brackets that work with an archwire to move individual teeth. The brackets remain in place temporarily during orthodontic…
Empower Clear is a family of single-use ceramic orthodontic brackets that work with an archwire to move individual teeth. The brackets remain in place temporarily during orthodontic treatment and are removed when treatment is complete.
The bracket bodies are made from alumina ceramic and incorporate a self-ligating clip. That clip retains the archwire at the bracket, forming the connection through which the wire acts on the tooth.
Listed Item
Cosmetic SL Empower Clear Interact LL 2ND Bicuspid 022 T-17 A+2 R=0 W/HK Dist
Tooth-Specific Geometry
Bracket geometries vary with the intended tooth. Their shape affects both the fit against the tooth and the direction in which force from the archwire is transmitted, so the family includes different bracket configurations for different tooth positions.
1manufacturer
250catalogue numbers in this listing
3510(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 | American Orthodontics, 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, Complaint-file establishment, Manufacturer |
| 510(k) | K122753 |
| Record published | 2016-12-20 |
| Record revised | 2026-03-23 (version 7) |
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 |
| Distribution end date | 2026-03-23 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1475-18-230HD | In distribution | |
| 1475-18-4412 | Withdrawn | |
| 1475-18-330HD | Withdrawn | |
| 1475-18-3522 | Withdrawn | |
| 1475-18-2210 | Withdrawn | |
| 1485-22-4522 | Withdrawn | |
| 1485-22-3517HD | Withdrawn | |
| 1485-22-4407HD | Withdrawn | |
| 1475-18-3101 | Withdrawn | |
| 1475-18-4101 | Withdrawn | |
| 1485-22-4522 | Withdrawn | |
| 1485-22-4417HD | Withdrawn | |
| 1485-22-1412 | Withdrawn | |
| 1475-18-3106 | Withdrawn | |
| 1485-22-4106 | Withdrawn | |
| 1585-22-1407 | Withdrawn | |
| 1475-18-223 | Withdrawn | |
| 1475-18-130HD | Withdrawn | |
| 1475-18-130HD | Withdrawn | |
| 1475-18-4106 | Withdrawn | |
| 1485-22-1112 | Withdrawn | |
| 1475-18-1407 | Withdrawn | |
| 1475-18-2407HD | Withdrawn | |
| 1485-22-3522 | Withdrawn | |
| 1475-18-3517HD | Withdrawn | |
| 1485-22-2210 | Withdrawn | |
| 1485-22-4311HD | Withdrawn | |
| 1475-18-4412HD | Withdrawn | |
| 1585-22-130HD | Withdrawn | |
| 1485-22-228 | Withdrawn | |
| 1485-22-3101 | Withdrawn | |
| 1475-18-123 | Withdrawn | |
| 1485-22-3106 | Withdrawn | |
| 1585-22-4417HD | Withdrawn | |
| 1485-22-3517 | Withdrawn | |
| 1485-22-1412 | Withdrawn | |
| 1585-22-4412HD | Withdrawn | |
| 1485-22-4512HD | Withdrawn | |
| 1485-22-117 | Withdrawn | |
| 1485-22-3417HD | Withdrawn | |
| 1475-18-3417 | Withdrawn | |
| 1475-18-3522 | Withdrawn | |
| 1485-22-4101 | Withdrawn | |
| 1485-22-1112 | Withdrawn | |
| 1475-18-1407HD | Withdrawn | |
| 1475-18-1407HU | Withdrawn | |
| 1485-22-3417 | Withdrawn | |
| 1485-22-1302HD | Withdrawn | |
| 1585-22-3101 | Withdrawn | |
| 1475-18-3412 | Withdrawn | |
| 1475-18-1302HD | Withdrawn | |
| 1585-22-230HD | Withdrawn | |
| 1475-18-128 | Withdrawn | |
| 1485-22-217 | Withdrawn | |
| 1475-18-4417HD | Withdrawn | |
| 1475-18-117 | Withdrawn | |
| 1485-22-128 | Withdrawn | |
| 1485-22-2302HD | Withdrawn | |
| 1475-18-4412HD | Withdrawn | |
| 1475-18-3306HD | Withdrawn | |
| 1485-22-4417HD | Withdrawn | |
| 1475-18-228 | Withdrawn | |
| 1485-22-2112 | Withdrawn | |
| 1475-18-4306HD | Withdrawn | |
| 1485-22-430HD | Withdrawn | |
| 126-029934 | Withdrawn | |
| 1475-18-3517HD | Withdrawn | |
| 1475-18-3417HD | Withdrawn | |
| 1475-18-4522 | Withdrawn | |
| 1475-18-3311HD | Withdrawn | |
| 1585-22-3522HD | Withdrawn | |
| 1485-22-3417HD | Withdrawn | |
| 1475-18-2307 | Withdrawn | |
| 1475-18-3522HD | Withdrawn | |
| 1485-22-3522 | Withdrawn | |
| 1475-18-4522HD | Withdrawn | |
| 126-039382 | Withdrawn | |
| 1585-22-4522HD | Withdrawn | |
| 1485-22-3412 | Withdrawn | |
| 1485-22-4517 | Withdrawn | |
| 1475-18-3517 | Withdrawn | |
| 1485-22-4302HD | Withdrawn | |
| 1475-18-1307 | Withdrawn | |
| 1585-22-1407 | Withdrawn | |
| 1485-22-1407HU | Withdrawn | |
| 1475-18-1302HD | Withdrawn | |
| 1475-18-1307HD | Withdrawn | |
| 1475-18-3417HD | Withdrawn | |
| 1585-22-330HD | Withdrawn | |
| 1485-22-4417 | Withdrawn | |
| 126-029935 | Withdrawn | |
| 1475-18-3417 | Withdrawn | |
| 1485-22-2117 | Withdrawn | |
| 1485-22-230HU | Withdrawn | |
| 1485-22-1117 | Withdrawn | |
| 1475-18-3106 | Withdrawn | |
| 1485-22-430HD | Withdrawn | |
| 1485-22-4302HD | Withdrawn | |
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| 1485-22-3311HD | Withdrawn | |
| 1585-22-430HD | Withdrawn | |
| 1485-22-4517HD | Withdrawn | |
| 1475-18-2302HD | Withdrawn | |
| 1485-22-123 | Withdrawn | |
| 1475-18-2117 | Withdrawn | |
| 1475-18-4522 | Withdrawn | |
| 1475-18-2210 | Withdrawn | |
| 1475-18-4517 | Withdrawn | |
| 1485-22-3522HD | Withdrawn | |
| 1585-22-3417 | Withdrawn | |
| 1475-18-2407 | Withdrawn | |
| 1585-22-1407HD | Withdrawn | |
| 1485-22-3407HD | Withdrawn | |
| 1585-22-4417 | Withdrawn | |
| 1475-18-130HU | Withdrawn | |
| 1485-22-4517HD | Withdrawn | |
| 126-029933 | Withdrawn | |
| 1485-22-4101 | Withdrawn | |
| 1485-22-3407HD | Withdrawn | |
| 1475-18-3101 | Withdrawn | |
| 1475-18-230HD | Withdrawn | |
| 1475-18-3311HD | Withdrawn | |
| 1475-18-230HU | Withdrawn | |
| 1585-22-3412 | Withdrawn | |
| 1585-22-3522 | Withdrawn | |
| 1485-22-3512HD | Withdrawn | |
| 1585-22-430HD | Withdrawn | |
| 1475-18-1307HU | Withdrawn | |
| 1485-22-2117 | Withdrawn | |
| 1475-18-4517 | Withdrawn | |
| 1475-18-4417 | Withdrawn | |
| 1485-22-3302HD | Withdrawn | |
| 1485-22-4412 | Withdrawn | |
| 1485-22-4417 | Withdrawn | |
| 1485-22-3101 | Withdrawn | |
| 1475-18-230 | Withdrawn | |
| 1485-22-223 | Withdrawn | |
| 1485-22-4407HD | Withdrawn | |
| 1585-22-4517HD | Withdrawn | |
| 1485-22-3311HD | Withdrawn | |
| 1475-18-2307HD | Withdrawn | |
| 1485-22-3417 | Withdrawn | |
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| 1485-22-4106 | Withdrawn | |
| 1485-22-1407 | Withdrawn | |
| 126-029936 | Withdrawn | |
| 1485-22-230HD | Withdrawn | |
| 1475-18-330HD | Withdrawn | |
| 1485-22-2210 | Withdrawn | |
| 1475-18-1210 | Withdrawn | |
| 1485-22-1210 | Withdrawn | |
| 1585-22-4412 | Withdrawn | |
| 1585-22-130HD | Withdrawn | |
| 1485-22-4311HD | Withdrawn | |
| 1485-22-3522HD | Withdrawn | |
| 1585-22-4522 | Withdrawn | |
| 1475-18-3522HD | Withdrawn | |
| 1485-22-4512HD | Withdrawn | |
| 1475-18-2302HD | Withdrawn | |
| 1485-22-1117 | Withdrawn | |
| 126-029931 | Withdrawn | |
| 1485-22-2112 | Withdrawn | |
| 1485-22-4517 | Withdrawn | |
| 1485-22-4522HD | Withdrawn | |
| 1475-18-4517HD | Withdrawn | |
| 1485-22-130HU | Withdrawn | |
| 1475-18-2407 | Withdrawn | |
| 1585-22-3517HD | Withdrawn | |
| 1475-18-2307HU | Withdrawn | |
| 1485-22-230HD | Withdrawn | |
| 1485-22-228 | Withdrawn | |
| 1475-18-1210 | Withdrawn | |
| 1475-18-128 | Withdrawn | |
| 1475-18-130 | Withdrawn | |
| 1485-22-330HD | Withdrawn | |
| 1475-18-4522HD | Withdrawn | |
| 1485-22-4412HD | Withdrawn | |
| 1585-22-2407HD | Withdrawn | |
| 1485-22-3517HD | Withdrawn | |
| 1485-22-3412HD | Withdrawn | |
| 1475-18-430HD | Withdrawn | |
| 1485-22-3412HD | Withdrawn | |
| 1475-18-1407HD | Withdrawn | |
| 1475-18-3412HD | Withdrawn | |
| 126-038575 | Withdrawn | |
| 1485-22-330HD | Withdrawn | |
| 1475-18-4412 | Withdrawn | |
| 1475-18-1112 | Withdrawn | |
| 1585-22-3517 | Withdrawn | |
| 1585-22-2407 | Withdrawn | |
| 1485-22-4306HD | Withdrawn | |
| 126-029929 | Withdrawn | |
| 1485-22-4412 | Withdrawn | |
| 1475-18-3412 | Withdrawn | |
| 1475-18-4417 | Withdrawn | |
| 1475-18-4311HD | Withdrawn | |
| 1475-18-1117 | Withdrawn | |
| 1475-18-1112 | Withdrawn | |
| 1485-22-130HD | Withdrawn | |
| 1585-22-230HD | Withdrawn | |
| 1485-22-2407 | Withdrawn | |
| 1485-22-3106 | Withdrawn | |
| 1485-22-1210 | Withdrawn | |
| 1485-22-3412 | Withdrawn | |
| 1585-22-2407 | Withdrawn | |
| 1475-18-2407HU | Withdrawn | |
| 1475-18-3412HD | Withdrawn | |
| 1485-22-130HD | Withdrawn | |
| 1485-22-1307HD | Withdrawn | |
| 1485-22-4412HD | Withdrawn | |
| 1475-18-1117 | Withdrawn | |
| 126-038576 | Withdrawn | |
| 1485-22-2307HD | Withdrawn | |
| 1485-22-1302HD | Withdrawn | |
| 1485-22-2302HD | Withdrawn | |
| 1485-22-1407 | Withdrawn | |
| 126-029930 | Withdrawn | |
| 1585-22-3417HD | Withdrawn | |
| 1475-18-4101 | Withdrawn | |
| 1485-22-128 | Withdrawn | |
| 1475-18-217 | Withdrawn | |
| 1485-22-3306HD | Withdrawn | |
| 1475-18-228 | Withdrawn | |
| 126-029932 | Withdrawn | |
| 1585-22-330HD | Withdrawn | |
| 1585-22-2407HD | Withdrawn | |
| 1485-22-2407 | Withdrawn | |
| 1475-18-2112 | Withdrawn | |
| 1475-18-2112 | Withdrawn | |
| 1485-22-2407HD | Withdrawn | |
| 126-039383 | Withdrawn | |
| 1475-18-4106 | Withdrawn | |
| 1475-18-1407 | Withdrawn | |
| 1475-18-2117 | Withdrawn | |
| 1475-18-4417HD | Withdrawn | |
| 1485-22-3302HD | Withdrawn | |
| 1475-18-430HD | Withdrawn | |
| 1485-22-3517 | Withdrawn | |
| 1485-22-3512HD | Withdrawn | |
| 1475-18-2407HD | Withdrawn | |
| 1485-22-2407HU | Withdrawn | |
| 1485-22-2412 | Withdrawn | |
| 1475-18-4311HD | Withdrawn | |
| 1485-22-1407HD | Withdrawn | |
| 1475-18-3517 | Withdrawn | |
| 1485-22-4522HD | Withdrawn |
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 Bracket | American Orthodontics | 250 |
| InVu Ceramic Brackets | TP Orthodontics, Inc. | 226 |
| RadiancePlus | American Orthodontics | 179 |
| InVu Readi-Base Brackets | TP Orthodontics, Inc. | 173 |
Showing 12 of 399. All products under Bracket, Ceramic, Orthodontic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K232011 | 2023-07-07 |
| K122753 | 2012-12-14 |
| K080749 | 2008-08-04 |
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.