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510(k) K800827

Device
PREMIER ABSORBENT POINTS
Applicant
PREMIER DENTAL PRODUCTS CO.
510(k) number
K800827
Product code
EKN  
Decision
Substantially Equivalent (SESE)
Decision date
1980-04-29
Date received
1980-04-14
Regulation
872.3830
Classification name
Point, Paper, Endodontic
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 EKN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K843017ABSORBENT ENDODONTIC POINTUnited Dental Mfg., Inc.1985-01-09
K821625ENDODONTIC PAPERPOINTSRoeko1982-06-14
K812886ENDODONTIC PAPER POINTSUnited Dental Mfg., Inc.1981-11-16
K781605R&R ABSORBENT POINTSRansom and Randolph1978-10-10
K761203ABSORBENT POINTSJohnson & Johnson Professionals, Inc.1976-12-13
K760983ENDODONTIC INSTRUMENTSAdp Intl., Inc.1976-11-15

Legacy Summary#

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FDA Review#

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