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510(k) K936221

Device
PROBE TIP/PERI PROBE/PERI PROBE COMP.
Applicant
PD INTERNATIONAL AB
510(k) number
K936221
Product code
EIX  
Decision
Substantially Equivalent (SESE)
Decision date
1994-08-01
Date received
1993-12-27
Regulation
872.4565
Classification name
Probe, Periodontic
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ANNETTE MATTSSON
Address
Sloane SE

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EIX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K960245VIP VICTOR INTERACTIVE PROBEPro-Dentec1996-04-04
K944848THE VIVACARE T.P.S. PROBERms Div.1994-12-14
K890333ALBUMIN REAGENTAlpkem Corp.1989-02-17
K880827ACCUTEK PERIODONTAL PROBESweet Micro Systems, Inc.1988-04-12
K875076FLORIDA PROBEFlorida Probe Corp.1988-03-10
K870280ACCUDENT ACCUPROBEAccudent, Inc.1987-06-08
K871504DISPOSABLE PERIODONTAL PROBEPeriodontal Health Brush, Inc.1987-05-06
K823324DENTAL INSTRUMENTS - PROBESMiltex, Inc.1982-11-24

Legacy Summary#

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FDA Review#

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