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510(k) K781035

Device
PERIODONTAL INSTRUMENT #21 GOLDMAN-FOX
Applicant
PREMIER DENTAL PRODUCTS CO.
510(k) number
K781035
Product code
EMN  
Decision
Substantially Equivalent (SESE)
Decision date
1978-06-30
Date received
1978-06-19
Regulation
872.4565
Classification name
Scaler, Periodontic
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 EMN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K070127PLAQUE SCRAPER-A INTERPROXIMAL (BETWEEN TEETH) PLAQUE REMOVER, MODEL Z01, Z02Kevin Vu, Dds2007-03-29
K931330DENTAL INSTRUMENTS SCALERMinnesota Prophy Power, Inc.1994-01-26
K8517211200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERSArtiberia1985-07-02
K821786BEACH SCALERSPacific Dental Corp.1982-07-06

Legacy Summary#

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FDA Review#

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