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510(k) K915250

WIL-PDS & WIL-PDI CASTING ALLOYS by Wilde-USA, Inc. — Product Code EJH

K915250 is an FDA 510(k) premarket notification submitted by Wilde-USA, Inc. for the device "WIL-PDS & WIL-PDI CASTING ALLOYS". The FDA issued a decision of Substantially Equivalent on April 21, 1992. The device falls under product code EJH (Alloy, Metal, Base), a Class II device regulated under 21 CFR 872.3710. Wilde-USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1992
Date Received
November 15, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alloy, Metal, Base
Device Class
Class II
Regulation Number
872.3710
Review Panel
DE
Submission Type

Other clearances by Wilde-USA, Inc.

  • K913582 — COMPATIT R (June 24, 1993)
  • K915653 — KERAMAIL (April 8, 1993)
  • K913581 — WILDE ADHESIVE BONDING SYSTEM (February 26, 1993)
  • K923472 — COMPACOLOR (October 13, 1992)
  • K920649 — COMPASEP (July 23, 1992)
  • K913089 — WILDE LIGHT CURING COMPOSITE RESTORATIVE RESINS (April 21, 1992)
  • K912990 — CONVERBASE (March 25, 1992)
  • K920557 — WIL-O-DONT ORTHODONTIC MATERIAL/WIL-O-LUX (March 20, 1992)
  • K915654 — KERALLOY-D CAPS (March 2, 1992)
  • K912993 — WILDE DENTURE RESINS (February 3, 1992)

Other clearances for product code EJH

  • K123929 — BEGOPAL+ (March 14, 2013)
  • K040180 — CONTINUM V (March 4, 2004)
  • K040179 — CONTINUM (March 3, 2004)
  • K033356 — VERASOFT ES (December 30, 2003)
  • K033045 — DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST (December 23, 2003)
  • K032136 — WIROBOND C (September 4, 2003)
  • K031627 — NANO-TICROWN (June 11, 2003)
  • K030632 — PD CASTA-H (May 7, 2003)
  • K030416 — CERACAST-V (April 14, 2003)
  • K030161 — SUPERBOND (March 17, 2003)

FDA data resources