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510(k) K760956

SURGICAL MICRO DRILL by American Safety Equipment Corp. — Product Code DZA

K760956 is an FDA 510(k) premarket notification submitted by American Safety Equipment Corp. for the device "SURGICAL MICRO DRILL". The FDA issued a decision of Substantially Equivalent on November 19, 1976. The device falls under product code DZA (Drill, Dental, Intraoral), a Class I device regulated under 21 CFR 872.4130. American Safety Equipment Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1976
Date Received
November 1, 1976
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 American Safety Equipment Corp.

  • K801010 — KIRSCHNER WIRE (May 20, 1980)
  • K771699 — CARA-STAIN MODEL 3000 (September 13, 1977)
  • K760960 — SURGICAL WIRE DRIVER (November 19, 1976)
  • K760958 — SURGICAL OSCILLATING SAW (November 16, 1976)
  • K760957 — SURGICAL RECIPROCATING SAW (November 15, 1976)
  • K760959 — SURGICAL CHISEL (November 15, 1976)

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)
  • K914724 — ADA SHANK EXTENSION (July 27, 1993)
  • 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)

FDA data resources