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510(k) K801888

HANDPIECE, DENTAL by Aesculap Instruments Corp. — Product Code DZA

K801888 is an FDA 510(k) premarket notification submitted by Aesculap Instruments Corp. for the device "HANDPIECE, DENTAL". The FDA issued a decision of Substantially Equivalent on August 20, 1980. The device falls under product code DZA (Drill, Dental, Intraoral), a Class I device regulated under 21 CFR 872.4130. Aesculap Instruments Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1980
Date Received
July 28, 1980
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 Aesculap Instruments Corp.

  • K890182 — PROTEGRAFT DV 1500, 1900 & LOW POR, UNIGRAFT DV (February 28, 1990)
  • K885046 — INSITUCAT VALVE STRIPPER (February 28, 1990)
  • K890443 — CASPAR SCALP CLIP, APPLIER (June 15, 1989)
  • K893121 — ROBOTRAC (TM) RETRACTOR ARM (June 1, 1989)
  • K884057 — ELAN-E DISPOSABLE DRAPE (October 19, 1988)
  • K880704 — CERULLO SUCTION REGULATOR (March 29, 1988)
  • K860016 — AESCULAP BONE MILL (March 19, 1986)
  • K801886 — BURR, DENTAL (August 20, 1980)
  • K801887 — DRILL, DENTAL (August 20, 1980)
  • K792558 — CONTAINER SYSTEM (December 27, 1979)

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)
  • K801887 — DRILL, DENTAL (August 20, 1980)

FDA data resources