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510(k) K946073

Device
ORALVUE DENTAL MIRROR
Applicant
HINES GROUP LTD.
510(k) number
K946073
Product code
EAX  
Decision
Substantially Equivalent (SESE)
Decision date
1995-02-16
Date received
1994-12-07
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
RANDALPH DINES
Address
1562 First Ave. Suite 356 Nyw York NY US 10028 10028

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
K935906RANIR PLAX RXRanir/Dcp Corp.1994-09-02
K941574RETRO MIRRORUnion Broach, Div. Moyco Industries, Inc.1994-05-18
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#

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FDA Review#

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