FLI

FLI SIG CLR MBT 022(NON-EXT W/Torq Cusp) U/L WHK3 5-5 20 BKT

Registry build 21.09.26
1manufacturer
113catalogue numbers in this listing

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 FLI
Listed by RMO, 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, Manufacturer
Premarket notification Exempt
Record published 2024-08-22

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for FLI
Catalogue number Size Per pack Status
Q07526 5 In distribution
Q07207 5 In distribution
Q07506 5 In distribution
Q07310 5 In distribution
KQ07501 20 In distribution
Q07500 5 In distribution
Q07539 5 In distribution
Q07624 5 In distribution
Q07302 5 In distribution
Q07605 5 In distribution
KQ07303 6 In distribution
Q07234 5 In distribution
Q07224 5 In distribution
KQ07204 12 In distribution
Q07410 5 In distribution
Q07532 5 In distribution
KQ07201 20 In distribution
KQ07301 20 In distribution
Q07602 5 In distribution
Q07432 5 In distribution
Q07407 5 In distribution
Q07208 5 In distribution
KQ07602 20 In distribution
Q07232 5 In distribution
KQ07205 12 In distribution
Q07501 5 In distribution
Q07530 5 In distribution
Q07604 5 In distribution
Q07306 5 In distribution
Q07202 5 In distribution
Q07408 5 In distribution
KQ07200 In distribution
KQ07503 6 In distribution
Q07610 5 In distribution
Q07328 5 In distribution
Q07201 5 In distribution
Q07226 5 In distribution
Q07537 5 In distribution
KQ07603 6 In distribution
Q07427 5 In distribution
Q07514 5 In distribution
Q07620 5 In distribution
Q07414 5 In distribution
Q07403 5 In distribution
KQ07403 6 In distribution
Q07308 5 In distribution
Q07227 5 In distribution
Q07402 5 In distribution
Q07503 5 In distribution
Q07330 5 In distribution
Q07534 5 In distribution
Q07603 5 In distribution
Q07210 5 In distribution
Q07436 5 In distribution
Q07228 5 In distribution
Q07438 5 In distribution
Q07434 5 In distribution
Q07307 5 In distribution
KQ07202 20 In distribution
Q07230 5 In distribution
Q07430 5 In distribution
Q07538 5 In distribution
Q07220 5 In distribution
Q07439 5 In distribution
Q07305 5 In distribution
Q07334 5 In distribution
KQ07203 6 In distribution
Q07416 5 In distribution
Q07332 5 In distribution
Q07301 5 In distribution
Q07422 5 In distribution
Q07320 5 In distribution
Q07406 5 In distribution
Q07600 5 In distribution
Q07508 5 In distribution
Q07536 5 In distribution
Q07303 5 In distribution
Q07607 5 In distribution
Q07426 5 In distribution
Q07200 5 In distribution
Q07428 5 In distribution
Q07437 5 In distribution
KQ07505 12 In distribution
KQ07302 20 In distribution
Q07203 5 In distribution
Q07626 5 In distribution
Q07515 5 In distribution
Q07206 5 In distribution
Q07225 5 In distribution
Q07326 5 In distribution
Q07625 5 In distribution
Q07516 5 In distribution
KQ07402 20 In distribution
Q07502 5 In distribution
Q07400 5 In distribution
Q07415 5 In distribution
Q07510 5 In distribution
KQ07300 20 In distribution
Q07300 5 In distribution
Q07327 5 In distribution
Q07517 5 In distribution
Q07324 5 In distribution
Q07204 5 In distribution
KQ07401 20 In distribution
Q07417 5 In distribution
KQ07502 20 In distribution
Q07205 5 In distribution
Q07304 5 In distribution
Q07401 5 In distribution
Q07627 5 In distribution
Q07325 5 In distribution
Q07606 5 In distribution
Q07507 5 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
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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer