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510(k) K822610

Device
PRECAPSULED DENTAL AMALGAM
Applicant
SYNTEX DENTAL PRODUCTS, INC.
510(k) number
K822610
Product code
DZS  
Decision
Substantially Equivalent (SESE)
Decision date
1982-09-14
Date received
1982-08-30
Regulation
872.3110
Classification name
Capsule, Dental, Amalgam
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 DZS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K802967DISPERSALLOY-DISPERSED PHASE ALLOY SELF-Johnson & Johnson Professionals, Inc.1980-12-30
K781243MERCURY DISP. CAPSULELee Pharmaceuticals1978-09-20
K780966LEE-ALLOY DISPOSABLE CAPSULESLee Pharmaceuticals1978-08-21

Legacy Summary#

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FDA Review#

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