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

RECOVER

K Number: K863401 · Decision Nov 13, 1986
Classifications
1
FEI Numbers
205
Registration Numbers
205
Same Product Code
913
Applicant Total
72
Review Days
71

Basic Information

Device Name
RECOVER
K Number
K863401
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
872.3690
Medical Specialty
Dental
Decision
Substantially Equivalent
Applicant
SCIENTIFIC PHARMACEUTICALS, INC.
Date Received
September 3, 1986
Decision Date
November 13, 1986
Product Code
EBF
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
EBF Material, Tooth Shade, Resin

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K Number Device Name
K051952 EUGENONE
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K013555 SCI-PHARM POST SECURE
K001446 LIGHT-CURED ORTHODONTIC BAND CEMENT
K993324 CARBOCEM ZINC POLYCARBOXYLATE CEMENT
K982915 SCI-PHARM DFV VARNISH
K983305 SCI-PHARM DESENSITIZING VARNISH
K982913 ZINFOS ZINC PHOSPHATE CEMENT
K944466 SEALDENT
K930584 MAGNACORE
Search all 72 clearances from SCIENTIFIC PHARMACEUTICALS, INC. →