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510(k) K771005

NEW PODIATRY PRODUCTS by Dentronix, Inc. — Product Code HTZ

K771005 is an FDA 510(k) premarket notification submitted by Dentronix, Inc. for the device "NEW PODIATRY PRODUCTS". The FDA issued a decision of Substantially Equivalent on June 17, 1977. The device falls under product code HTZ (Instrument, Cutting, Orthopedic), a Class I device regulated under 21 CFR 878.4800. Dentronix, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1977
Date Received
June 2, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Cutting, Orthopedic
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Dentronix, Inc.

  • K910202 — DENTRONIX MODEL 2000 (March 13, 1991)
  • K880322 — DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEM (July 13, 1988)
  • K771006 — MODIFIED PODIATRY PRODUCTS (June 17, 1977)
  • K770302 — CUTTER, P606 BONE (March 9, 1977)
  • K770305 — CUTTER, P607 BONE (March 9, 1977)
  • K770304 — CUTTER, P605 GENERAL PURPOSE (March 9, 1977)
  • K770303 — NIPPER, NAIL, P610 ENGLISH (March 9, 1977)
  • K770301 — NIPPER, PSO4 TISSUE (March 7, 1977)

Other clearances for product code HTZ

  • K933933 — CEBOPLANE (April 15, 1994)
  • K931737 — HEDLEYL INTRAMEDULLARY PREPARATION BRUSH (January 7, 1994)
  • K870882 — 45 DEGREE SHAVER (March 23, 1987)
  • K853678 — KAMBIN SPINAL INSTRUMENT SET (September 24, 1985)
  • K850423 — CONCEPT SUCTION SLEEVE (March 14, 1985)
  • K850527 — ARTHROSCOPY SUCTION BIOPSY PUNCH (March 14, 1985)
  • K841980 — SIDE CUTTING SERRATED BLADE (August 15, 1984)
  • K842774 — CODMAN SUCTION PUNCH-PRODUCT CODES (July 27, 1984)
  • K841978 — LATERAL RELEASE KNIFE 5MM & 7MM (June 19, 1984)
  • K841973 — BANANA KNIFE SERRATED (June 19, 1984)

FDA data resources