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510(k) K780400

Device
DEN-Z-ORB
Applicant
NICE-PAK PRODUCTS, INC.
510(k) number
K780400
Product code
KHR  
Decision
Substantially Equivalent (SESE)
Decision date
1978-03-27
Date received
1978-03-13
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
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

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
K771908ISO-SHIELD SALIVA ABSORBERS3M Company1977-11-07

Legacy Summary#

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FDA Review#

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