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510(k) K830109

CIMPAT by North Pacific Dental, Inc. — Product Code EMR

K830109 is an FDA 510(k) premarket notification submitted by North Pacific Dental, Inc. for the device "CIMPAT". The FDA issued a decision of Substantially Equivalent on March 1, 1983. The device falls under product code EMR (File, Periodontic), a Class I device regulated under 21 CFR 872.4565. North Pacific Dental, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1983
Date Received
January 11, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by North Pacific Dental, Inc.

  • K830113 — SEPTOPACK (May 9, 1983)
  • K830111 — SEPTOCAL (March 24, 1983)
  • K830106 — UNICIDE (March 7, 1983)
  • K830117 — ENDOMET (March 1, 1983)
  • K830114 — GUTTA PERCHA POINTS (March 1, 1983)
  • K830105 — VITATHYL (March 1, 1983)
  • K830115 — PAPER POINTS (March 1, 1983)
  • K830116 — SULCARINGS (February 18, 1983)
  • K830107 — SELFAST (February 18, 1983)
  • K830112 — HYDROL (February 18, 1983)

FDA data resources