FDA.reportPublic FDA data

510(k) K883403

Device
Denta Plus
Applicant
CONNOISSEURS PRODUCTS CORP.
510(k) number
K883403
Product code
JER
Decision
Substantially Equivalent (SESE)
Decision date
1988-10-25
Date received
1988-08-11
Regulation
872.3530
Classification name
Cleaner, Denture, Mechanical
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
KARL KALTENBACH
Address
100 Fellsway W. Somerville MA US 02145 02145

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JER#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K881391ULTRASONIC DENTURE CLEANERTatung Company of America, Inc.1988-08-26
K872521DENTURE CLEANSERSDental Research Laboratories1987-08-11
K852906DURACLEAN DENTURE CLEANERAstron Dental Corp.1985-07-31
K840805ORAL SAFEGreat Lakes Orthodontics, Ltd.1984-03-30
K832359ORAL SAFEGreat Lakes Orthodontics, Ltd.1983-09-26
K832387DENTURE CLEANERTower Laboratories, Ltd.1983-09-12
K800166DENTSPLY DENTURE CLEANERDentsply Intl.1980-03-17
K792530PLAQUE-X DENTURE CLEANERNexell Corp.1979-12-27
K791925DEN-MAT 4-MINUTE DENTURE CLEANERDen-Mat Corp.1979-10-26
K791716PLAQUE-X DENTURE CLEANSERNoxell1979-10-23
K781779SANI-DENT DENTURE CLEANERSandi-Dent1978-11-08
K780254DENTURE CLEANSER & TOOTHPASTE IN ONERichardson Merrel, Inc.1978-03-09
K780174ORABRITENorcliff Thayer, Inc.1978-02-23