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510(k) K931329

DENTAL INSTRUMENTS CURETTE PERIODONTAL by Minnesota Prophy Power, Inc. — Product Code EMS

K931329 is an FDA 510(k) premarket notification submitted by Minnesota Prophy Power, Inc. for the device "DENTAL INSTRUMENTS CURETTE PERIODONTAL". The FDA issued a decision of Substantially Equivalent on January 27, 1994. The device falls under product code EMS (Curette, Periodontic), a Class I device regulated under 21 CFR 872.4565. Minnesota Prophy Power, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1994
Date Received
March 16, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Minnesota Prophy Power, Inc.

  • K931330 — DENTAL INSTRUMENTS SCALER (January 26, 1994)

Other clearances for product code EMS

  • K872091 — CURRETTES, ALVEOLAR (MOLT AND MILLER) (July 31, 1987)
  • K870590 — CURETTE, PERIODONTAL, COLUMBIA UNIVERSITY (April 16, 1987)
  • K841011 — ELEVATOR - VARIOUS (June 15, 1984)
  • K834072 — INSTRUMENT, DENTAL (February 21, 1984)
  • K823319 — DENTAL INSTRUMENTS - SCALERS (November 24, 1982)
  • K821789 — BEACH CURETTE NO. 2 AND NO. 3 T.G. (July 6, 1982)

FDA data resources