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510(k) K914724

ADA SHANK EXTENSION by Implant Corp. of America — Product Code DZA

K914724 is an FDA 510(k) premarket notification submitted by Implant Corp. of America for the device "ADA SHANK EXTENSION". The FDA issued a decision of Substantially Equivalent on July 27, 1993. The device falls under product code DZA (Drill, Dental, Intraoral), a Class I device regulated under 21 CFR 872.4130. Implant Corp. of America has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1993
Date Received
October 18, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drill, Dental, Intraoral
Device Class
Class I
Regulation Number
872.4130
Review Panel
DE
Submission Type

Other clearances by Implant Corp. of America

  • K914715 — PARALLELING GUIDES (February 16, 1994)
  • K914714 — BONE DRILLS OR TAPS (November 15, 1993)

Other clearances for product code DZA

  • K984508 — SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/ (June 25, 1999)
  • K962979 — S-53 INTRORAL DENTAL SYSTEM (September 25, 1996)
  • K954790 — PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS (January 16, 1996)
  • K905418 — GATES GLIDDEN DRILLS (July 25, 1991)
  • K901097 — FILLOCK REAMER (April 25, 1990)
  • K896149 — ANEST-EZE DENTAL DRILL RA#2 (January 19, 1990)
  • K884187 — INDENTEC DRILL RA #1 (December 22, 1988)
  • K811113 — RIESS-LUHR (June 16, 1981)
  • K801888 — HANDPIECE, DENTAL (August 20, 1980)
  • K801887 — DRILL, DENTAL (August 20, 1980)

FDA data resources