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510(k) K810524

SR-IVOTRAY SPECIAL by J. Aderer, Inc. — Product Code EHY

K810524 is an FDA 510(k) premarket notification submitted by J. Aderer, Inc. for the device "SR-IVOTRAY SPECIAL". The FDA issued a decision of Substantially Equivalent on March 17, 1981. The device falls under product code EHY (Tray, Impression, Preformed), a Class I device regulated under 21 CFR 872.6880. J. Aderer, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1981
Date Received
February 26, 1981
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 J. Aderer, Inc.

  • K822957 — PURCAST (October 26, 1982)
  • K822956 — G CAST (October 26, 1982)
  • K821798 — 82 ALLOY (July 13, 1982)
  • K821832 — DEGUCAST U (July 6, 1982)
  • K821590 — PORS-ON (June 14, 1982)
  • K821572 — DUALLOR 'R' (June 14, 1982)
  • K821407 — DEVA M (June 9, 1982)
  • K821521 — STABILOR NF (June 9, 1982)
  • K821446 — DEGUDENT 14 (June 9, 1982)
  • K821613 — E.G. BRIDGE GOLD (June 4, 1982)

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)
  • K841323 — FUZZY TRAY (June 27, 1984)
  • K833485 — IMPRESSION TUBE ADJUSTABLE (December 26, 1983)

FDA data resources