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510(k) K841323

FUZZY TRAY by Buffalo Dental Mfg. Co., Inc. — Product Code EHY

K841323 is an FDA 510(k) premarket notification submitted by Buffalo Dental Mfg. Co., Inc. for the device "FUZZY TRAY". The FDA issued a decision of Substantially Equivalent on June 27, 1984. The device falls under product code EHY (Tray, Impression, Preformed), a Class I device regulated under 21 CFR 872.6880. Buffalo Dental Mfg. Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1984
Date Received
April 2, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Impression, Preformed
Device Class
Class I
Regulation Number
872.6880
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)
  • K941954 — NON-FOGGING DENTAL MIRROR (July 8, 1994)
  • K841491 — CONVENTIONAL PLASTIC DENTAL TRAYS (July 13, 1984)
  • K841490 — POLYSULFIDE CUSTOM TRAY MATERIAL (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 EHY

  • K942668 — O-TRAY IMPRESSION TRAYS (July 22, 1994)
  • K896470 — EOS IMPRESSION TRAYS (February 9, 1990)
  • K884316 — OCCLUSAL HARMONY IMPRESSION TRAY (December 22, 1988)
  • K863836 — POST TRAY (October 14, 1986)
  • K850776 — PREFORMED DENTAL IMPRESSION TRAYS (March 18, 1985)
  • K842274 — F-G-P TRAY (July 31, 1984)
  • K842273 — CROWN INDEX TRAY (July 31, 1984)
  • K841491 — CONVENTIONAL PLASTIC DENTAL TRAYS (July 13, 1984)
  • K833485 — IMPRESSION TUBE ADJUSTABLE (December 26, 1983)
  • K810524 — SR-IVOTRAY SPECIAL (March 17, 1981)

FDA data resources