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510(k) K911285

Device
PULPDENT POLYAMIDE DENTIN LINER
Applicant
PULPDENT CORP.
510(k) number
K911285
Product code
EME  
Decision
Substantially Equivalent (SESE)
Decision date
1991-10-09
Date received
1991-03-19
Regulation
872.4565
Classification name
Punch, Biopsy, Surgical
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
KENNETH J BERK
Address
80 Oakland St. P.O. Box 780 Watertown MA US 02471 02471

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EME  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K933670BIOPSY PUNCH, SURGICALByron Medical1994-01-07
K884740EURO-MED LIGHT TOUCH BIOPSY PUNCHBuckman Co., Inc.1989-03-06

Legacy Summary#

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FDA Review#

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