Nova-S Sapphire

.018 Ubicr Nova-S Sapphire Bracket - HK MBT (5)

Registry build 21.09.26
1manufacturer
18catalogue 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
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 2022-04-30

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
Catalogue number Size Status
.018 U1R In distribution
.018 LA In distribution
.018 U2R In distribution
.018 UBICR-HK In distribution
.018 L5L In distribution
.018 U3L -HK In distribution
.018 L4L -HK In distribution
.018 L3R -HK In distribution
.018 U3R-HK In distribution
.018 L3L -HK In distribution
.018 UBIC In distribution
.018 L5R-HK In distribution
.018 U1L In distribution
.018 UBICL -HK In distribution
.018 LBIC In distribution
.018 LBIC In distribution
.018 U2L In distribution
.018 L4R-HK 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