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510(k) K812886

ENDODONTIC PAPER POINTS by United Dental Mfg., Inc. — Product Code EKN

K812886 is an FDA 510(k) premarket notification submitted by United Dental Mfg., Inc. for the device "ENDODONTIC PAPER POINTS". The FDA issued a decision of Substantially Equivalent on November 16, 1981. The device falls under product code EKN (Point, Paper, Endodontic), a Class I device regulated under 21 CFR 872.3830. United Dental Mfg., Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1981
Date Received
October 14, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Point, Paper, Endodontic
Device Class
Class I
Regulation Number
872.3830
Review Panel
DE
Submission Type

Other clearances by United Dental Mfg., Inc.

  • K843017 — ABSORBENT ENDODONTIC POINT (January 9, 1985)
  • K823684 — FILE TYPE K ENDODONTIC (December 28, 1982)
  • K823685 — FILE TYPE H (HEDSTROEM) ENDODONTIC (December 28, 1982)
  • K823686 — REAMER TYPE K ENDODONTIC (December 28, 1982)

Other clearances for product code EKN

  • K843017 — ABSORBENT ENDODONTIC POINT (January 9, 1985)
  • K821625 — ENDODONTIC PAPERPOINTS (June 14, 1982)
  • K800827 — PREMIER ABSORBENT POINTS (April 29, 1980)
  • K781605 — R&R ABSORBENT POINTS (October 10, 1978)
  • K761203 — ABSORBENT POINTS (December 13, 1976)
  • K760983 — ENDODONTIC INSTRUMENTS (November 15, 1976)

FDA data resources