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510(k) K911643

Device
ABIODENT PERIOTEMP(R) SYSTEM
Applicant
ABIOMED, INC.
510(k) number
K911643
Product code
EIL  
Decision
Substantially Equivalent (SESE)
Decision date
1991-07-09
Date received
1991-04-12
Regulation
872.4565
Classification name
Gauge, Depth, Instrument, Dental
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
BRUCE J SHOOK
Address
33 Cherry Hill Dr. Danvers MA US 01923 01923

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EIL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K890493FLORIDA PROBE PERIODONTAL PROBEFlorida Probe Corp.1989-03-13
K885075ABIOMED PERIOTEMP(TM) PROBEAbiomed, Inc.1989-02-13
K884813MODEL 200A ELECTRONIC FORCE-SENSING PROBEVine Valley Research1989-01-05
K880209PERIODONTAL PROBE - AUTOPROBEDentsply Intl.1988-04-27
K872098CREMEEN ALVEOLAR BONE CALIPERBowen & Company, Inc.1987-07-31
K872215PERIO-TESTDr. Bernard Loewenthal1987-07-10
K822793PIO ROOT CANAL INDICATORNational Patent Development Corp.1982-10-22

Legacy Summary#

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FDA Review#

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