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510(k) K864572

FIXTECTOR by Prodent Intl., Inc. — Product Code EFH

K864572 is an FDA 510(k) premarket notification submitted by Prodent Intl., Inc. for the device "FIXTECTOR". The FDA issued a decision of Substantially Equivalent on February 12, 1987. The device falls under product code EFH (Paper, Articulation), a Class I device regulated under 21 CFR 872.6140. Prodent Intl., Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1987
Date Received
November 20, 1986
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 by Prodent Intl., Inc.

  • K904296 — LYSTA HYGIENIST III SCALER (December 5, 1990)

Other clearances for product code EFH

  • K965026 — PFINGST PRESSURE PASTE (February 10, 1997)
  • K912632 — OCCLUDE (January 17, 1992)
  • K911259 — HYDENT (June 6, 1991)
  • 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