FDA 510(k) Premarket Notification K093019: ENAMELITE ACRYSEAL SPRAY SEALANT

Submission Details & Decision

Normalized public record details for 510(k) notification K093019.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K093019

Applicant / Sponsor

Enamelite, LLC

Device Name

ENAMELITE ACRYSEAL SPRAY SEALANT

Product Code

EBD

Decision Date

2009-12-22

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Dental (DE)

Clearance Type

Traditional

Third Party Flag

Date Received

2009-09-29

Related Establishments / Registrations

FIVE STAR ORTHODONTIC LABORATORY & SUPPLY, INC. Registration: 1000118628 View Registration
BREDENT GMBH & CO.KG Registration: 1000303432 View Registration
DREVE DENTAMID GMBH Registration: 1000486347 View Registration
VITA ZAHNFABRIK H. RAUTER GMBH & CO. KG. Registration: 1000625496 View Registration
PULPDENT CORPORATION Registration: 1215305 View Registration
GC AMERICA INC. Registration: 1410097 View Registration
BISCO, INC. Registration: 1420052 View Registration
RELIANCE ORTHODONTIC PRODUCTS, INC. Registration: 1420089 View Registration
COSMEDENT, INC. Registration: 1450653 View Registration
DENTONICS, INC. Registration: 1721647 View Registration
DEN-MAT HOLDINGS, LLC Registration: 2018957 View Registration
SCIENTIFIC PHARMACEUTICALS, INC. Registration: 2022039 View Registration
PAC-DENT INC. Registration: 2086043 View Registration
GEORGE TAUB PRODUCTS & FUSION CO., INC. Registration: 2241860 View Registration
PARKELL, INC. Registration: 2411797 View Registration
DENTSPLY LLC Registration: 2424472 View Registration
DENTSPLY LLC Registration: 2515379 View Registration
SHOFU DENTAL CORP. Registration: 2916735 View Registration
DELTAMED GMBH Registration: 3002789526 View Registration
GC CORPORATION-FUJI OYAMA FACTORY Registration: 3002807050 View Registration
SHOFU INC. Registration: 3002808149 View Registration
GC ASAHI CORPORATION Registration: 3004146043 View Registration
Ivoclar Vivadent GmbH Registration: 3004966444 View Registration
KULZER GMBH Registration: 3005665377 View Registration
indigodental GmbH Registration: 3006694515 View Registration
Yamahachi Dental Material (Changshu) Co., Ltd. Registration: 3006942327 View Registration
SAMTRADE SUPPLIES INC. Registration: 3008912871 View Registration
IVOCLAR VIVADENT, INC. Registration: 3009496224 View Registration
JERSEY DENTAL SUPPLIES Registration: 3012187973 View Registration
MAINLINE MEDICAL DENTAL SUPPLY Registration: 3012421607 View Registration
M/S LEIXIR RESOURCES PVT. LTD Registration: 3014270094 View Registration
WORLDWIDE SUPPLIES LIMITED Registration: 3014579161 View Registration
YAMAHACHI DENTAL MFG. CO. Registration: 3020841418 View Registration
Solventum Germany GmbH Registration: 3035693034 View Registration
OKETZ LOGISTICS LLC Registration: 3038718579 View Registration
ID KOREA CO., LTD. Registration: 3039359767 View Registration
VOCO GMBH Registration: 8010908 View Registration
DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH Registration: 8044164 View Registration
KULZER GMBH Registration: 9610902 View Registration
Solventum Germany GmbH Registration: 9611385 View Registration
GC CORP. Registration: 9612300 View Registration
IVOCLAR VIVADENT AG Registration: 9612352 View Registration
GC DENTAL PRODUCTS CORP. Registration: 9613953 View Registration

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