FDA 510(k) Premarket Notification K875144: EXCEL FAST SET

Submission Details & Decision

Normalized public record details for 510(k) notification K875144.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K875144

Applicant / Sponsor

Reliance Orthodontic Products, Inc.

Device Name

EXCEL FAST SET

Product Code

DYH

Decision Date

1988-02-26

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Dental (DE)

Clearance Type

Traditional

Third Party Flag

Date Received

1987-12-15

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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This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.