Empower Clear Bracket

Cosmetic SL Empower Clear Interact LR 1ST BIC 022 T-12 A+2 R=0 W/HK Dist

Registry build 21.09.26
1manufacturer
250catalogue numbers in this listing
3510(k) clearances naming this product code

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code NJM
Manufacturer City Province Registered as Device types
Wuxi TP Orthodontics Material Co., Ltd. Wuxi Jiangsu Repacker / relabeller 9

Record

Regulatory record for Empower Clear Bracket
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 2026-03-23

Specifications

Specifications
MRI safety MR Unsafe
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for Empower Clear Bracket
Catalogue number Size Status
1475-18-1407CC In distribution
1485-22-123CC In distribution
1485-22-117 In distribution
1475-18-128 In distribution
1485-22-4412HD In distribution
1475-18-4522CC In distribution
1485-22-3522 In distribution
1585-22-130HDCC In distribution
1585-22-4417HD In distribution
1485-22-130HD In distribution
1485-22-1117 In distribution
1585-22-2407CC In distribution
126-029934 In distribution
1485-22-2407 In distribution
1485-22-4412CC In distribution
1485-22-1302HDCC In distribution
1585-22-1407HDCC In distribution
1485-22-4517HDCC In distribution
1585-22-1407HD In distribution
1475-18-3412 In distribution
1485-22-2412CC In distribution
1475-18-2302HDCC In distribution
1475-18-1302HD In distribution
1485-22-430HDCC In distribution
1485-22-3512HDCC In distribution
1485-22-1412CC In distribution
1485-22-4101 In distribution
1585-22-130HD In distribution
1585-22-4412 In distribution
1485-22-3412CC In distribution
1475-18-1117 In distribution
1475-18-1210CC In distribution
1475-18-1302HDCC In distribution
1585-22-4517HDCC In distribution
1475-18-3412HD In distribution
1585-22-3412 In distribution
1585-22-4517HD In distribution
1475-18-1117CC In distribution
1475-18-2407 In distribution
1485-22-3302HDCC In distribution
1475-18-130HD In distribution
1475-18-330HDCC In distribution
1485-22-4417HDCC In distribution
1475-18-223CC In distribution
1485-22-2302HDCC In distribution
1485-22-4417HD In distribution
1485-22-4106CC In distribution
1475-18-4517CC In distribution
1485-22-3106 In distribution
1475-18-4517 In distribution
1475-18-4101 In distribution
1475-18-2210 In distribution
1475-18-128CC In distribution
1475-18-4417HDCC In distribution
1485-22-3412HDCC In distribution
1485-22-4522CC In distribution
1585-22-330HD In distribution
1475-18-4522 In distribution
1485-22-130HDCC In distribution
1475-18-3417HD In distribution
1485-22-430HD In distribution
126-038575 In distribution
1485-22-1302HD In distribution
1475-18-130HDCC In distribution
1485-22-2302HD In distribution
1475-18-3106CC In distribution
1485-22-1407 In distribution
1485-22-3417CC In distribution
1585-22-3522HDCC In distribution
126-029932 In distribution
1485-22-128CC In distribution
1485-22-3106CC In distribution
1475-18-3522CC In distribution
1585-22-4412HD In distribution
1585-22-3417HDCC In distribution
1485-22-3302HD In distribution
1475-18-1407 In distribution
1475-18-117 In distribution
1475-18-230HDCC In distribution
1475-18-123 In distribution
1475-18-2117CC In distribution
1585-22-2407HD In distribution
1585-22-4517CC In distribution
1485-22-330HDCC In distribution
1485-22-2112CC In distribution
1485-22-4522HDCC In distribution
1485-22-4106 In distribution
1485-22-4512HDCC In distribution
1585-22-3517HDCC In distribution
1475-18-4311HDCC In distribution
1475-18-1407HD In distribution
1485-22-2407HDCC In distribution
1485-22-223 In distribution
1485-22-3407HDCC In distribution
1485-22-1117CC In distribution
1485-22-4407HD In distribution
1485-22-4412HDCC In distribution
1585-22-3412CC In distribution
1485-22-128 In distribution
1475-18-230HD In distribution
1585-22-4412HDCC In distribution
1485-22-3522HDCC In distribution
1475-18-217CC In distribution
1585-22-4522 In distribution
1475-18-2407HD In distribution
1475-18-3522HD In distribution
1475-18-117CC In distribution
1475-18-3412CC In distribution
1485-22-3412HD In distribution
1475-18-3517HD In distribution
1475-18-3417 In distribution
1475-18-3106 In distribution
1585-22-3417HD In distribution
1585-22-430HD In distribution
1485-22-2112 In distribution
1485-22-3517HD In distribution
1475-18-3417CC In distribution
1585-22-3417CC In distribution
1485-22-2412 In distribution
1485-22-1407CC In distribution
126-029935 In distribution
1485-22-230HD In distribution
1585-22-4522HDCC In distribution
1585-22-3517HD In distribution
1485-22-4311HDCC In distribution
1485-22-4522HD In distribution
1585-22-430HDCC In distribution
1475-18-4106 In distribution
1475-18-3517CC In distribution
1485-22-2210CC In distribution
1485-22-3517CC In distribution
1475-18-1210 In distribution
1485-22-3522HD In distribution
1585-22-4417 In distribution
1485-22-3407HD In distribution
1485-22-4517 In distribution
1585-22-3412HDCC In distribution
1485-22-4512HD In distribution
1485-22-3412 In distribution
1475-18-123CC In distribution
1475-18-4517HD In distribution
1475-18-2117 In distribution
1475-18-4412 In distribution
1475-18-3517HDCC In distribution
1485-22-4311HD In distribution
1485-22-2117 In distribution
1485-22-1112CC In distribution
1585-22-4412CC In distribution
1485-22-217 In distribution
1475-18-4417 In distribution
1475-18-430HDCC In distribution
1475-18-223 In distribution
1475-18-4412HDCC In distribution
1585-22-4522CC In distribution
1475-18-4101CC In distribution
1475-18-228 In distribution
126-029936 In distribution
1485-22-330HD In distribution
1485-22-1412 In distribution
1585-22-4417HDCC In distribution
1475-18-2112 In distribution
1485-22-3417HD In distribution
1475-18-3517 In distribution
1485-22-117CC In distribution
1485-22-3311HD In distribution
1585-22-3522 In distribution
1585-22-230HD In distribution
1585-22-330HDCC In distribution
1475-18-4412HD In distribution
1475-18-430HD In distribution
1585-22-3522CC In distribution
1475-18-2407HDCC In distribution
1485-22-4412 In distribution
1475-18-4417CC In distribution
1475-18-217 In distribution
1485-22-228CC In distribution
1585-22-3417 In distribution
1475-18-4522HDCC In distribution
1475-18-2210CC In distribution
1475-18-3101CC In distribution
1485-22-2407HD In distribution
126-029933 In distribution
1585-22-4417CC In distribution
1475-18-1112 In distribution
1485-22-2117CC In distribution
126-029930 In distribution
1485-22-228 In distribution
1585-22-230HDCC In distribution
1485-22-4417CC In distribution
1585-22-4517 In distribution
1485-22-3517 In distribution
1485-22-4302HDCC In distribution
1585-22-1407CC In distribution
1485-22-4302HD In distribution
1475-18-4412CC In distribution
1485-22-230HDCC In distribution
1475-18-4522HD In distribution
1485-22-1407HDCC In distribution
1475-18-330HD In distribution
1475-18-3522 In distribution
1475-18-1112CC In distribution
1485-22-3522CC In distribution
1475-18-3417HDCC In distribution
1585-22-3412HD In distribution
1485-22-3101 In distribution
1485-22-3311HDCC In distribution
1485-22-3512HD In distribution
1475-18-4311HD In distribution
1485-22-4417 In distribution
126-039383 In distribution
1585-22-2407HDCC In distribution
1585-22-3517 In distribution
1485-22-4522 In distribution
1485-22-223CC In distribution
1585-22-4522HD In distribution
1485-22-1210 In distribution
1475-18-1407HDCC In distribution
1475-18-2302HD In distribution
1475-18-228CC In distribution
126-039382 In distribution
1485-22-123 In distribution
1585-22-1407 In distribution
1485-22-1407HD In distribution
1485-22-3417 In distribution
1475-18-3311HDCC In distribution
1475-18-4106CC In distribution
1475-18-2407CC In distribution
1485-22-4101CC In distribution
1485-22-4517CC In distribution
1485-22-4407HDCC In distribution
1475-18-3101 In distribution
1485-22-2407CC In distribution
1485-22-3517HDCC In distribution
1585-22-2407 In distribution
1485-22-1210CC In distribution
1485-22-4517HD In distribution
1485-22-1112 In distribution
126-038576 In distribution
1585-22-3522HD In distribution
1475-18-4417HD In distribution
1475-18-3522HDCC In distribution
1485-22-3417HDCC In distribution
1485-22-2210 In distribution
1585-22-3517CC In distribution
1485-22-217CC In distribution
1475-18-4517HDCC In distribution
1475-18-3412HDCC In distribution
1475-18-2112CC In distribution
1475-18-3311HD In distribution
1485-22-3101CC In distribution

Same Product Code

Other products under the same FDA 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
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

FDA 510(k) clearances naming this product code
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.

Where China Actually Supplies

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2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer