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510(k) K830106

UNICIDE by North Pacific Dental, Inc. — Product Code LFE

K830106 is an FDA 510(k) premarket notification submitted by North Pacific Dental, Inc. for the device "UNICIDE". The FDA issued a decision of Substantially Equivalent on March 7, 1983. The device falls under product code LFE (Solution, Cold Sterilizing), a Class II device regulated under 21 CFR 880.6885. North Pacific Dental, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 1983
Date Received
January 11, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solution, Cold Sterilizing
Device Class
Class II
Regulation Number
880.6885
Review Panel
DE
Submission Type

Other clearances by North Pacific Dental, Inc.

  • K830113 — SEPTOPACK (May 9, 1983)
  • K830111 — SEPTOCAL (March 24, 1983)
  • K830105 — VITATHYL (March 1, 1983)
  • K830115 — PAPER POINTS (March 1, 1983)
  • K830117 — ENDOMET (March 1, 1983)
  • K830114 — GUTTA PERCHA POINTS (March 1, 1983)
  • K830109 — CIMPAT (March 1, 1983)
  • K830107 — SELFAST (February 18, 1983)
  • K830116 — SULCARINGS (February 18, 1983)
  • K830112 — HYDROL (February 18, 1983)

FDA data resources