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510(k) K920557

WIL-O-DONT ORTHODONTIC MATERIAL/WIL-O-LUX by Wilde-USA, Inc. — Product Code EBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 1992
Date Received
February 5, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resin, Denture, Relining, Repairing, Rebasing
Device Class
Class II
Regulation Number
872.3760
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)
  • K915250 — WIL-PDS & WIL-PDI CASTING ALLOYS (April 21, 1992)
  • K913089 — WILDE LIGHT CURING COMPOSITE RESTORATIVE RESINS (April 21, 1992)
  • K912990 — CONVERBASE (March 25, 1992)
  • K915654 — KERALLOY-D CAPS (March 2, 1992)
  • K912993 — WILDE DENTURE RESINS (February 3, 1992)

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  • K250302 — Flexible Partial Resin (June 25, 2025)
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  • K250489 — FP3D (May 20, 2025)
  • K250617 — Apex Flex (April 29, 2025)
  • K243356 — Asiga DentaBASE (April 11, 2025)