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510(k) K965026

PFINGST PRESSURE PASTE by Pfingst & Co., Inc. — Product Code EFH

K965026 is an FDA 510(k) premarket notification submitted by Pfingst & Co., Inc. for the device "PFINGST PRESSURE PASTE". The FDA issued a decision of Substantially Equivalent on February 10, 1997. The device falls under product code EFH (Paper, Articulation), a Class I device regulated under 21 CFR 872.6140.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1997
Date Received
December 17, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Paper, Articulation
Device Class
Class I
Regulation Number
872.6140
Review Panel
DE
Submission Type

Other clearances for product code EFH

  • K912632 — OCCLUDE (January 17, 1992)
  • K911259 — HYDENT (June 6, 1991)
  • K864572 — FIXTECTOR (February 12, 1987)
  • K870032 — REVISED T-SCAN SYSTEM (February 2, 1987)
  • K832647 — ARTICULATING PAPER (February 21, 1984)
  • K833132 — MUCOSAL ADJUSTMENT PASTE LIQUID SPRAY (February 10, 1984)
  • K810498 — CENTRIC (BITE) REGISTRATION PASTE (March 17, 1981)
  • K771011 — ARTICULATING PAPER (June 20, 1977)
  • K770492 — CRACK DETECTOR, DEN-MAT (March 21, 1977)

FDA data resources