Nova-S-Sapphire Bracket

.022 Ubicr Nova -S Sapphire Bracket W- HK Roth (5)

Registry build 21.09.26
1manufacturer
57catalogue 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 Nova-S-Sapphire Bracket
Listed by Ortho Arch Company Inc, United States
FDA product code NJM
Device type Bracket, Ceramic, Orthodontic
Device class Class 2
Regulation 21 CFR 872.5470
Establishment Repacker / relabeller
510(k) K142729
Record published 2022-06-01

Specifications

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

Catalogue Numbers

Catalogue numbers for Nova-S-Sapphire Bracket
Catalogue number Size Status
.022 L5L 17T In distribution
.018 L4L 17T HOOK In distribution
.022 U3L HK MBT In distribution
.022 L4L 12T HOOK In distribution
466-461 In distribution
.022 UBICR HK MBT In distribution
466-433 In distribution
.022 U1R MBT In distribution
.018 U2L ROTH In distribution
.018 LA ROTH In distribution
.018 L5L 22T HOOK In distribution
.022 L3R HK MBT In distribution
.018 L4R 17T HOOK In distribution
466-445 In distribution
.022 UBICL MBT In distribution
466-432 In distribution
.022 LA MBT In distribution
.022 L4R 12T HOOK In distribution
.022 L5R 17T In distribution
466-463 In distribution
.022 L3L HK MBT In distribution
.022 U1L MBT In distribution
.022 UBICR HK ROTH In distribution
022 L4L 12T In distribution
.018 L3L HK ROTH In distribution
.018 UBIC ROTH In distribution
.022 U1R MBT In distribution
.022 UBICL – MBT In distribution
.022 U3L HK ROTH In distribution
.022 U2R ROTH In distribution
.018 U3L HK ROTH In distribution
466-471 In distribution
.022 U1L ROTH In distribution
.018 UBICL HK ROTH In distribution
.022 U3R HK MBT In distribution
.018 U1L ROTH In distribution
.018 UBICR HK ROTH In distribution
466-451 In distribution
.018 L3R HK ROTH In distribution
.022 L5R 17T HOOK In distribution
466-472 In distribution
.018 U3R HK ROTH In distribution
.022 L4R 12T In distribution
.022 U1R ROTH In distribution
.018 LBIC 22T In distribution
.018 L5R 22T HOOK In distribution
466-452 In distribution
.022 U3R HK ROTH In distribution
.022 U2L ROTH In distribution
466-462 In distribution
.018 U1R ROTH In distribution
.018 LBIC In distribution
.018 U2R ROTH In distribution
.022 U1L MBT In distribution
.022 L5L 17T HOOK In distribution
.022 UBICL HK MBT In distribution
466-473 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