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510(k) K935127

SOUTHLAND STERILE DENTAL SYSTEM by Southland, Ltd. — Product Code EKJ

K935127 is an FDA 510(k) premarket notification submitted by Southland, Ltd. for the device "SOUTHLAND STERILE DENTAL SYSTEM". The FDA issued a decision of Substantially Equivalent on July 28, 1994. The device falls under product code EKJ (Burnisher, Operative), a Class I device regulated under 21 CFR 872.4565.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1994
Date Received
October 28, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Burnisher, Operative
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances for product code EKJ

  • K961714 — ASEPTYLUM, UNI-CARRIER (June 10, 1996)
  • K953707 — MEDTROL DENTAL KIT (January 4, 1996)
  • K945815 — DENTAL KIT (July 19, 1995)
  • K951607 — SUREFLEX FILES (June 22, 1995)
  • K945077 — INSTRUMENT,FILLING,PLASTIC,DENTAL (November 30, 1994)
  • K943820 — STAT PAK (November 2, 1994)
  • K943351 — MAUNAL DISPOSABLE DENTAL INSTRUMENTS (October 7, 1994)
  • K943584 — PRESTERILIZED ENDODONTIC FILES (September 21, 1994)
  • K941954 — NON-FOGGING DENTAL MIRROR (July 8, 1994)
  • K925115 — AMD DENTIST AND HYGIENIST KITS (July 5, 1994)

FDA data resources