FDA.reportPublic FDA data

510(k) K941574

Device
RETRO MIRROR
Applicant
UNION BROACH, DIV. MOYCO INDUSTRIES, INC.
510(k) number
K941574
Product code
EAX  
Decision
Substantially Equivalent (SESE)
Decision date
1994-05-18
Date received
1994-03-31
Regulation
872.4565
Classification name
Mirror, Mouth
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
CHRIS M LEHR
Address
Division Of Moyco Ind., Inc. P.O. Box 508, Aberdeen Rd. Emigsville PA US 17318 17318

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EAX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K946073ORALVUE DENTAL MIRRORHines Group , Ltd.1995-02-16
K935906RANIR PLAX RXRanir/Dcp Corp.1994-09-02
K935687NILDentalsafe Systems Pty., Ltd.1994-02-03
K863766DISPOSABLE MOUTH MIRRORS, SINGLE USE ONLYThe Medical Group, Inc.1986-10-30
K863767GLASS MOUTH MIRRORS, REUSABLEThe Medical Group, Inc.1986-10-30
K833310FOGCUTTER DENTAL MOUTH MIRRORHti, Inc.1984-05-07
K841199FIBERGLASS MOUTH MIRRORSHenry Schein, Inc.1984-04-25
K833429PERI MIRROR/SALIVA EJECTORDentec, Inc.1983-12-22
K830777ELECTRIC MOUTH MIRRORAlmore Intl., Inc.1983-04-06
K821777BEACH MOUTH MIRRORPacific Dental Corp.1982-07-06
K800919ORAVIEW BY WATER PIKTeledyne, Inc.1980-05-08

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases