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510(k) K780619

PREFORMED TOOTH POSITIONER by Tp Laboratories, Inc. — Product Code KMY

K780619 is an FDA 510(k) premarket notification submitted by Tp Laboratories, Inc. for the device "PREFORMED TOOTH POSITIONER". The FDA issued a decision of Substantially Equivalent on June 28, 1978. The device falls under product code KMY (Positioner, Tooth, Preformed), a Class I device regulated under 21 CFR 872.5525.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1978
Date Received
April 13, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Positioner, Tooth, Preformed
Device Class
Class I
Regulation Number
872.5525
Review Panel
DE
Submission Type

Other clearances for product code KMY

  • K931615 — NITE-GUIDE (April 14, 1995)
  • K942667 — DENT-O-CRYL ORTHODONTIC ACRYLIC (February 13, 1995)
  • K924351 — GLENROE ELASTIBITE STIMULATOR (January 6, 1994)
  • K925064 — RELAX-O-GUARD (September 13, 1993)
  • K924975 — THE ORTHOTRAINER (July 8, 1993)
  • K924974 — THE TMJ APPLIANCE (June 23, 1993)
  • K904128 — PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER (November 9, 1990)
  • K891328 — PREFORMED TEMPLATE FOR TOOTH POSITIONER (March 31, 1989)
  • K833455 — REMOLDABLE CRANIOMANDIBULAR APPLIANCE (January 10, 1984)
  • K831793 — AQUALIZER MOUTHPIECE (August 12, 1983)

FDA data resources