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510(k) K941954

NON-FOGGING DENTAL MIRROR by Buffalo Dental Mfg. Co., Inc. — Product Code EKJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1994
Date Received
April 22, 1994
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

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  • K820489 — ULTRAFINE TRAY ADHESIVE (March 19, 1982)
  • K820216 — ULTRA-WET (February 24, 1982)
  • K802990 — ALGINATE/SILICONE CROWN & BRIDGE MATER (February 2, 1981)
  • K802882 — HYDROCOLLOID COMPATIBLE CREAM ALGINATE (January 28, 1981)
  • K802662 — POLYCARBONATE TEMPORARY CEMENT (December 16, 1980)

Other clearances for product code EKJ

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  • 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)
  • K935127 — SOUTHLAND STERILE DENTAL SYSTEM (July 28, 1994)
  • K925115 — AMD DENTIST AND HYGIENIST KITS (July 5, 1994)