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510(k) K070127

Device
PLAQUE SCRAPER-A INTERPROXIMAL (BETWEEN TEETH) PLAQUE REMOVER, MODEL Z01, Z02
Applicant
KEVIN VU, DDS
510(k) number
K070127
Product code
EMN  
Decision
Substantially Equivalent (SESE)
Decision date
2007-03-29
Date received
2007-01-16
Regulation
872.4565
Classification name
Scaler, Periodontic
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Glen Feye
Address
1340 W Pennsylvania Ave. San Diego CA US 92103 92103

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EMN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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
K781035PERIODONTAL INSTRUMENT #21 GOLDMAN-FOXPremier Dental Products Co.1978-06-30

Legacy Summary#

summary

FDA Review#

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