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510(k) K051077

E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101 by Aseptico, Inc. — Product Code EGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2005
Date Received
April 27, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Handpiece, Contra- And Right-Angle Attachment, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

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  • K030895 — ASEPTICO ENDOPEX V, MODEL AEU-40 (December 3, 2003)
  • K030163 — ASEPTICO VCT VERSATILE COMMAND TECHNOLOGY MODEL AEU-925 (March 3, 2003)

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