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510(k) K912989

PLANUSTAR AND DENS NOBILIS DENTURE TEETH by Wilde-USA, Inc. — Product Code EMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 1991
Date Received
July 8, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
File, Bone, Surgical
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

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  • 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)
  • K920557 — WIL-O-DONT ORTHODONTIC MATERIAL/WIL-O-LUX (March 20, 1992)
  • K915654 — KERALLOY-D CAPS (March 2, 1992)

Other clearances for product code EMI

  • K914035 — MINI-MILL (March 2, 1992)
  • K851716 — 865/1 TO 875/3 VARIOUS TYPES OF DENTAL BONE FILES (June 11, 1985)
  • K823676 — DISC NEEDLE SET #TX-8220 (January 9, 1983)