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510(k) K802990

ALGINATE/SILICONE CROWN & BRIDGE MATER by Buffalo Dental Mfg. Co., Inc. — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1981
Date Received
November 24, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Impression
Device Class
Class II
Regulation Number
872.3660
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)
  • K841323 — FUZZY TRAY (June 27, 1984)
  • K820489 — ULTRAFINE TRAY ADHESIVE (March 19, 1982)
  • K820216 — ULTRA-WET (February 24, 1982)
  • K802882 — HYDROCOLLOID COMPATIBLE CREAM ALGINATE (January 28, 1981)
  • K802662 — POLYCARBONATE TEMPORARY CEMENT (December 16, 1980)

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