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510(k) K911259

HYDENT by Pascal Co., Inc. — Product Code EFH

K911259 is an FDA 510(k) premarket notification submitted by Pascal Co., Inc. for the device "HYDENT". The FDA issued a decision of Substantially Equivalent on Jun 6, 1991. The device falls under product code EFH (Paper, Articulation), a Class I device regulated under 21 CFR 872.6140. Pascal Co., Inc. has 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 6, 1991
Date Received
Mar 22, 1991
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
510(k) Exempt

Other clearances by Pascal Co., Inc.

  • K102526 — BLO2X OXYGEN BLOCKER (Oct 22, 2010)
  • K090597 — FLUORILAQ SODIUM FLUORIDE CAVITY VARNISH (Mar 16, 2009)
  • K040988 — ZIRCON-F PROPHYLAXIS PASTE (Jul 7, 2004)
  • K040661 — RADENT PROPHY PASTE (Jun 9, 2004)
  • K012889 — BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT (May 27, 2003)
  • K030488 — FLUORILAQ (May 2, 2003)
  • K912632 — OCCLUDE (Jan 17, 1992)

Other clearances for product code EFH

  • K965026 — PFINGST PRESSURE PASTE (Feb 10, 1997)
  • K912632 — OCCLUDE (Jan 17, 1992)
  • K864572 — FIXTECTOR (Feb 12, 1987)
  • K870032 — REVISED T-SCAN SYSTEM (Feb 2, 1987)
  • K832647 — ARTICULATING PAPER (Feb 21, 1984)
  • K833132 — MUCOSAL ADJUSTMENT PASTE LIQUID SPRAY (Feb 10, 1984)
  • K810498 — CENTRIC (BITE) REGISTRATION PASTE (Mar 17, 1981)
  • K771011 — ARTICULATING PAPER (Jun 20, 1977)
  • K770492 — CRACK DETECTOR, DEN-MAT (Mar 21, 1977)

FDA data resources

Source: FDA 510(k) database entry for K911259. Report a data issue: hello@regdatalab.com.