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510(k) K864376

FIBERBOND by Dentec, Inc. — Product Code DYT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 1987
Date Received
November 5, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Maintainer, Space Preformed, Orthodontic
Device Class
Class I
Regulation Number
872.5525
Review Panel
DE
Submission Type

Other clearances by Dentec, Inc.

  • K894930 — DENTEC 4000 (March 27, 1990)
  • K833429 — PERI MIRROR/SALIVA EJECTOR (December 22, 1983)

Other clearances for product code DYT

  • K935856 — DENTAURUM SPACE MAINTAINER (April 28, 1994)
  • K812239 — UNITEK PALATAL BAR (September 21, 1981)
  • K780814 — SAFETY STOP NECKSTRAP (June 30, 1978)