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510(k) K821798

82 ALLOY by J. Aderer, Inc. — Product Code EJS

K821798 is an FDA 510(k) premarket notification submitted by J. Aderer, Inc. for the device "82 ALLOY". The FDA issued a decision of Substantially Equivalent on July 13, 1982. The device falls under product code EJS (Alloy, Other Noble Metal), a Class II device regulated under 21 CFR 872.3060. J. Aderer, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 1982
Date Received
June 18, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alloy, Other Noble Metal
Device Class
Class II
Regulation Number
872.3060
Review Panel
DE
Submission Type

Other clearances by J. Aderer, Inc.

  • K822957 — PURCAST (October 26, 1982)
  • K822956 — G CAST (October 26, 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)
  • K821446 — DEGUDENT 14 (June 9, 1982)
  • K821521 — STABILOR NF (June 9, 1982)
  • K821613 — E.G. BRIDGE GOLD (June 4, 1982)
  • K821299 — CER-MATE (May 28, 1982)

Other clearances for product code EJS

  • K041433 — BRIGHT GOLD XH (August 19, 2004)
  • K040436 — SIMIDUR SUPERIOR (March 5, 2004)
  • K022252 — STERNGOLD 1, MODEL 1127781 (September 19, 2002)
  • K022469 — ECO E4 (September 18, 2002)
  • K021367 — STERNGOLD 66, MODEL #1180230 (May 16, 2002)
  • K020195 — SIMIDUR S1S (March 15, 2002)
  • K020192 — SIMIDUR S2 (March 15, 2002)
  • K020194 — SIMIDUR KF PLUS (March 15, 2002)
  • K014042 — D.SIGN 84 (February 22, 2002)
  • K013809 — D.SIGN 59 (February 7, 2002)

FDA data resources