Home / 510(k) Clearances / K973062

510(k) K973062

TWIST RECIPROCATING DISPOSABLE PROPHY ANGLE by Medidenta Intl., Inc. — Product Code EFA

K973062 is an FDA 510(k) premarket notification submitted by Medidenta Intl., Inc. for the device "TWIST RECIPROCATING DISPOSABLE PROPHY ANGLE". The FDA issued a decision of Substantially Equivalent on October 9, 1997. The device falls under product code EFA (Handpiece, Belt And/Or Gear Driven, Dental), a Class I device regulated under 21 CFR 872.4200.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 1997
Date Received
August 18, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Belt And/Or Gear Driven, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

Other clearances for product code EFA

  • K192809 — Dental Handpiece (August 25, 2020)
  • K163239 — SMARTmatic (March 17, 2017)
  • K143465 — MASTERmatic LUX (April 9, 2015)
  • K101172 — RDT3 HANDPIECE HEAD MODEL RDT3 (July 27, 2010)
  • K093894 — ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE (March 3, 2010)
  • K092446 — INTRA LUX HEAD 3 LDSY (November 3, 2009)
  • K090055 — LOW & HIGH SPEED KIT (October 27, 2009)
  • K092412 — STRONG IMPLANT HANDPIECES (September 3, 2009)
  • K090676 — MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES (May 22, 2009)
  • K070084 — MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL (March 8, 2007)

FDA data resources