FDA.reportPublic FDA data

510(k) K850014

Device
Hit Kit (hydrodynamic Impression Technique
Applicant
MEDI-DENT AMERICAN, INC.
510(k) number
K850014
Product code
EBH
Decision
Substantially Equivalent (SESE)
Decision date
1985-01-23
Date received
1985-01-02
Regulation
872.3670
Classification name
Material, Impression Tray, Resin
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JOHN R MINICUCCI
Address
110 24th St. Niagara Falls NY US 14303 14303

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EBH#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K933745PERMAGEN UNIVERSAL BONDING RESINBio-Systems Research1994-01-26
K930487PALATRAY LC MINTHeraeus Kulzer, Inc.1993-06-18
K923979LC TRAY MATERIALDentsply Intl.1992-11-17
K923549PALADISC LCHeraeus Kulzer, Inc.1992-09-29
K912820POLYESTER RESIN HAND MOLDED TRAYE&D Dental Products, Inc.1991-08-21
K905058PALAVIT LKulzer, Inc.1991-06-06
K902350PALATRAY LC RESIN IMPRESSION TRAY MATERIALKulzer, Inc.1990-07-26
K901782CONVERTRAY CUSTOM IMPRESSION TRAY MATERIAL SYSTEMProductivity Training Corp.1990-06-29
K890712ADVANTAGE DENTAL CUST DENT IMPRESS/BASEPLATE TRAYSAdvantage Dental Products, Inc.1989-04-25
K881838MODIFIED PERMAGUM ADHESIVEEspe GmbH (Us)1988-07-27
K875228PERMADYNE ADHESIVEEspe GmbH (Us)1988-03-09
K875257IMPREGUM F ADHESIVEEspe GmbH (Us)1988-03-09
K873739ACRYLIC IMPRESSION TRAY MATERIALSE&D Dental Manufacturing Co.1988-03-07
K872210IMPRESSION TRAYDentsply Intl.1987-06-22
K863421SR-IVOLEN TRAY MATERIALIvoclar USA, Inc.1986-11-03