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510(k) K984508

SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MOD by W&H Dentalwerk Buermoos GmbH — Product Code DZA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1999
Date Received
December 18, 1998
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

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Other clearances for product code DZA

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