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510(k) K811665

SR-ISOCETTE by J. Aderer, Inc. — Product Code ELK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 1981
Date Received
June 15, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Teeth, Artificial, Backing And Facing
Device Class
Class I
Regulation Number
872.3910
Review Panel
DE
Submission Type

Other clearances by J. Aderer, Inc.

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  • 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 ELK

  • K760909 — THERMOMETER JARS AND CAPS (December 30, 1976)