FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

DMG-POLISHABLE COMPOSITE

K Number: K810813 · Decision Apr 14, 1981
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
51
Applicant Total
2
Review Days
21

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Basic Information

Device Name
DMG-POLISHABLE COMPOSITE
K Number
K810813
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
872.3310
Medical Specialty
Dental
Decision
Substantially Equivalent
Applicant
Dental-Material Gesellschaft
Date Received
March 24, 1981
Decision Date
April 14, 1981
Product Code
EBD
Advisory Committee
Dental
Review Advisory Committee
DE
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
EBD Coating, Filling Material, Resin

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Other 510(k) clearances with the same product code (EBD), ordered by most recent decision date.

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Other Clearances by Dental-Material Gesellschaft

K Number Device Name
K810825 POLYVINYL SILICONE IMPRESSION MATERIAL