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510(k) K832366

ZOLLER BURNED LIP CONFORMER by Universal Prosthetics, Inc. — Product Code EIG

K832366 is an FDA 510(k) premarket notification submitted by Universal Prosthetics, Inc. for the device "ZOLLER BURNED LIP CONFORMER". The FDA issued a decision of Substantially Equivalent on September 26, 1983. The device falls under product code EIG (Retractor, All Types), a Class I device regulated under 21 CFR 872.4565. Universal Prosthetics, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1983
Date Received
July 18, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retractor, All Types
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Universal Prosthetics, Inc.

  • K813132 — THE CHICAGO GULLET (January 7, 1982)
  • K811428 — NORTHWESTERN VOICE RESTORATION KIT (June 16, 1981)

Other clearances for product code EIG

  • K971284 — OPALDAM (June 3, 1997)
  • K854711 — FIBRELIGHT ILLUMINATING ORAL RETRACTORS (February 25, 1986)
  • K821784 — BEACH GINGIVAL RETRACTION INSTR. TYPE B (July 6, 1982)
  • K771973 — GINGITRACT (November 7, 1977)
  • K771399 — LIP & CHEEK RETRACTOR (August 26, 1977)
  • K761024 — RACESTYPTINE RINGS (November 19, 1976)
  • K760657 — RACESTYPTINE CORD (September 27, 1976)

FDA data resources