FDA 510(k) Premarket Notification K161684: Quantum LB

Submission Details & Decision

Normalized public record details for 510(k) notification K161684.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K161684

Applicant / Sponsor

Reliance Orthodontic Products, Inc.

Device Name

Quantum LB

Product Code

DYH

Decision Date

2016-10-06

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Dental (DE)

Clearance Type

Traditional

Third Party Flag

Date Received

2016-06-17

Related Establishments / Registrations

FIVE STAR ORTHODONTIC LABORATORY & SUPPLY, INC. Registration: 1000118628 View Registration
B.J.M. LABORATORIES LTD Registration: 1000272892 View Registration
PULPDENT CORPORATION Registration: 1215305 View Registration
GC AMERICA INC. Registration: 1410097 View Registration
DENTAL TECHNOLOGIES, INC. Registration: 1413475 View Registration
BISCO, INC. Registration: 1420052 View Registration
RELIANCE ORTHODONTIC PRODUCTS, INC. Registration: 1420089 View Registration
PRIME DENTAL MANUFACTURING, INC. Registration: 1424442 View Registration
COSMEDENT, INC. Registration: 1450653 View Registration
RMO Registration: 1718476 View Registration
Ultradent Products Inc. Registration: 1718912 View Registration
DENTONICS, INC. Registration: 1721647 View Registration
TP ORTHODONTICS, INC. Registration: 1815540 View Registration
DEN-MAT HOLDINGS, LLC Registration: 2018957 View Registration
SCIENTIFIC PHARMACEUTICALS, INC. Registration: 2022039 View Registration
ZEST ANCHORS, LLC Registration: 2023950 View Registration
Kerr Corporation Registration: 2024312 View Registration
YOUNG INNOVATIONS INC. Registration: 2024980 View Registration
DENT ZAR, INC. Registration: 2027375 View Registration
AMERICAN ORTHODONTICS Registration: 2126683 View Registration
PREMIER DENTAL PRODUCTS CO. Registration: 2511556 View Registration
GC CORPORATION-FUJI OYAMA FACTORY Registration: 3002807050 View Registration
ADITEK DO BRASIL, SA Registration: 3003622434 View Registration
GESTENCO INTERNATIONAL AB Registration: 3004109528 View Registration
MICERIUM S.P.A. Registration: 3004130302 View Registration
SPECIALTY APPLIANCES, LLC Registration: 3004158247 View Registration
SYNCA MARKETING Registration: 3006697692 View Registration
Conamco SA de CV Medental Inc Registration: 3006805063 View Registration
medmix Deutschland GmbH Registration: 3007113445 View Registration
DENTSCARE LTDA Registration: 3007210751 View Registration
MANI MEDICAL GERMANY GmbH Registration: 3007584711 View Registration
US ORTHODONTIC PRODUCTS Registration: 3008005217 View Registration
INTERNATIONAL ORTHODONTIC SERVICES, PC Registration: 3008524225 View Registration
Xplora USA LLC Registration: 3008882689 View Registration
SAMTRADE SUPPLIES INC. Registration: 3008912871 View Registration
GC Orthodontics America Inc. Registration: 3010032042 View Registration
O&S Dental, Inc. Registration: 3010065389 View Registration
3D DENTAL DESINGS AND DEVELOPMENT Registration: 3010864832 View Registration
JERSEY DENTAL SUPPLIES Registration: 3012187973 View Registration
MAINLINE MEDICAL DENTAL SUPPLY Registration: 3012421607 View Registration
SANICURE BV Registration: 3012494290 View Registration
VIARDEN LAB LLC Registration: 3012996495 View Registration
Ortho Pro Dent LLC Registration: 3013410675 View Registration
Ormco Corporation Registration: 3013508670 View Registration
JMU DENTAL, INC Registration: 3014683120 View Registration
Ormco Corporation Registration: 3015272949 View Registration
CSY INTERNATIONAL LLC Registration: 3016543896 View Registration
FIRST DENTAL SUPPLIES LLC Registration: 3022296393 View Registration
GC Dental Mexicana, S.A. de C.V. Registration: 3027241817 View Registration
Solventum US LLC Registration: 3031841433 View Registration
Solventum Orthodontics Corporation Registration: 3032027578 View Registration
Solventum US LLC Registration: 3032163716 View Registration
Kerr Corporation Registration: 3032378317 View Registration
Solventum Poland Manufacturing SP. ZO.O Registration: 3032763783 View Registration
OKETZ LOGISTICS LLC Registration: 3038718579 View Registration
SOLVENTUM US LLC Registration: 3042272797 View Registration
VOCO GMBH Registration: 8010908 View Registration
Dentaurum GmbH & Co. KG Registration: 9611458 View Registration
GC CORP. Registration: 9612300 View Registration
GC DENTAL PRODUCTS CORP. Registration: 9613953 View Registration
SDS de Mexico S. de R.L. de C.V. Registration: 9680845 View Registration
S & C POLYMER GMBH Registration: 9681210 View Registration

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