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510(k) K952868

Device
DENTAURUM JACKET CROWN & ROOT POSTS
Applicant
DENTAURAUM, INC.
510(k) number
K952868
Product code
EBL  
Decision
Substantially Equivalent (SESE)
Decision date
1995-07-19
Date received
1995-06-22
Regulation
872.3740
Classification name
Pin, Retentive And Splinting, And Accessory Instruments
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JOHN J ROTH, JR.
Address
10 Pheasant Run Newtown PA US 18940 18940

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EBL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K002693CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIECE AND BURS)Cbs Intl. B.V.2000-11-09
K924376ROOT CANAL POSTThe Thera Group1993-11-22
K895283PROSTHETIC RESTORATION DEVICESwiss Precision Mfg. Corp.1990-02-14
K895758PLASTIC TOOTH REINFORCEMENT KITNanzee Dental Products1989-12-20
K883074ELGILOYDale T. Dupuis1988-08-09
K863831VIVADENT FILPINVivadent (Usa), Inc.1986-10-14
K844457SECURIPINHughes Int'L, Inc.1984-12-27
K830773MARKLEY THREADED WIREAlmore Intl., Inc.1983-04-28
K822412REINFORCING PINFilhol1982-08-30
K760723SAFE-T-PINS RETENTIVE PIN SYSTEMParkell, Inc.1976-10-21

Legacy Summary#

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FDA Review#

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