FDA 510(k) FDA class 1 Substantially Equivalent 🇫🇷 France

IMPLANTEO IMPLANTOLOGY MOTOR

K Number: K041279 · Decision Sep 23, 2004
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
88
Applicant Total
10
Review Days
133

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Basic Information

Device Name
IMPLANTEO IMPLANTOLOGY MOTOR
K Number
K041279
Device Class
FDA class 1
Clearance Type
Abbreviated
Regulation Number
872.4200
Medical Specialty
Dental
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Anthogyr
Date Received
May 13, 2004
Decision Date
September 23, 2004
Product Code
EKX
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
EKX Handpiece, Direct Drive, Ac-Powered

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K230680 Anthogyr Surgical Cassettes
K160730 Instrument kits
K093894 ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE
K090676 MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES
K040671 EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES
K040674 IMPLANTOLOGY CONTRA ANGLES, ENDODONTIC CONTRA ANGLES, GENERAL DENTISTRY CONTRA ANGLES