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510(k) K810977

ENDODONTIC POST SYSTEMS by Preat Corp. — Product Code ECG

K810977 is an FDA 510(k) premarket notification submitted by Preat Corp. for the device "ENDODONTIC POST SYSTEMS". The FDA issued a decision of Substantially Equivalent on May 13, 1981. The device falls under product code ECG (Sterilizer, Boiling Water), a Class I device regulated under 21 CFR 872.6710.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1981
Date Received
April 10, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Boiling Water
Device Class
Class I
Regulation Number
872.6710
Review Panel
DE
Submission Type

Other clearances for product code ECG

  • K895164 — EAGLE DS (November 17, 1989)
  • K843234 — CITOMAT AUTOCLAVES (October 25, 1984)
  • K811237 — MAGNETIC RETENTION UNIT (June 16, 1981)
  • K790290 — NEY EQUI-HINGE (April 10, 1979)
  • K790078 — BAR & RIDER, SCREWS, TUBES (February 27, 1979)
  • K771266 — STEAM STERILIZER (August 2, 1977)

FDA data resources