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510(k) K941954

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

K941954 is an FDA 510(k) premarket notification submitted by Buffalo Dental Mfg. Co., Inc. for the device "NON-FOGGING DENTAL MIRROR". The FDA issued a decision of Substantially Equivalent on July 8, 1994. The device falls under product code EKJ (Burnisher, Operative), a Class I device regulated under 21 CFR 872.4565. Buffalo Dental Mfg. Co., Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by Buffalo Dental Mfg. Co., Inc.

  • K955573 — OPTIBLAST INTRAORAL SANDBLASTER (May 3, 1996)
  • K945220 — AMALGAM CARRIER (January 11, 1995)
  • K841491 — CONVENTIONAL PLASTIC DENTAL TRAYS (July 13, 1984)
  • K841490 — POLYSULFIDE CUSTOM TRAY MATERIAL (June 27, 1984)
  • K841323 — FUZZY TRAY (June 27, 1984)
  • 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

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

FDA data resources