FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇭 Switzerland

DENTAL SCREW POSTS

K Number: K931396 · Decision Apr 28, 1994
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
34
Applicant Total
3
Review Days
405

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Basic Information

Device Name
DENTAL SCREW POSTS
K Number
K931396
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
872.3810
Medical Specialty
Dental
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Harald Nordin S.A
Date Received
March 19, 1993
Decision Date
April 28, 1994
Product Code
ELR
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
ELR Post, Root Canal

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Other Clearances by Harald Nordin S.A

K Number Device Name
K003221 HARALD NORDIN GLASSIX GLASS FIBER COMPOSITE DENTAL POST
K003219 HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST