FDA.reportPublic FDA data

510(k) K771908

Device
Iso-shield Saliva Absorbers
Applicant
3M COMPANY
510(k) number
K771908
Product code
KHR
Decision
Substantially Equivalent (SESE)
Decision date
1977-11-07
Date received
1977-10-11
Regulation
872.6050
Classification name
Absorber, Saliva, Paper
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
8124 Pacific Ave. White City OR US 97503 97503

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KHR#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K980783SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5Irt Management Corp.1998-04-21
K954068GENERAL HYGIENE KITPhysician Industries, Inc.1995-11-08
K953812GAUZE SPONGERemington Medical, Inc.1995-10-02
K891054NON-STERILE GAUZE SPONGEDispomed, Inc.1989-05-01
K891354ORTHODONTIC COTTON ROLL HOLDERSAmerican Orthodontics1989-04-17
K890734DRY TIPSMicrocopy, Div. Neo-Flo, Inc.1989-03-10
K870383ALGINATE WOOL FIBERAdri1987-04-30
K850988BOVO MOISTURE GUARDE.H. Medical Co.1985-04-16
K780400DEN-Z-ORBNice-Pak Products, Inc.1978-03-27