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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 June 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 at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1991
Date Received
March 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

Other clearances by Pascal Co., Inc.

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

Other clearances for product code EFH

  • K965026 — PFINGST PRESSURE PASTE (February 10, 1997)
  • K912632 — OCCLUDE (January 17, 1992)
  • 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