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

ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE

K Number: K093894 · Decision Mar 3, 2010
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
24
Applicant Total
10
Review Days
75

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Basic Information

Device Name
ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE
K Number
K093894
Device Class
FDA class 1
Clearance Type
Special
Regulation Number
872.4200
Medical Specialty
Dental
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Anthogyr
Date Received
December 18, 2009
Decision Date
March 3, 2010
Product Code
EFA
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
EFA Handpiece, Belt And/Or Gear Driven, Dental

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K230680 Anthogyr Surgical Cassettes
K160730 Instrument kits
K090676 MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES
K040671 EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES
K041279 IMPLANTEO IMPLANTOLOGY MOTOR
K040674 IMPLANTOLOGY CONTRA ANGLES, ENDODONTIC CONTRA ANGLES, GENERAL DENTISTRY CONTRA ANGLES