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

UNIVERSAL FIX-A-PLATE

K Number: K833057 · Decision Feb 27, 1984
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
6
Applicant Total
2
Review Days
173

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Basic Information

Device Name
UNIVERSAL FIX-A-PLATE
K Number
K833057
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
872.3570
Medical Specialty
Dental
Decision
Substantially Equivalent
Applicant
Laurentian Laboratories
Date Received
September 7, 1983
Decision Date
February 27, 1984
Product Code
EBO
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
EBO Denture Repair Kit

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Other Clearances by Laurentian Laboratories

K Number Device Name
K833056 UNIVERSAL LINE-A-PLATE