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510(k) K811665

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

K811665 is an FDA 510(k) premarket notification submitted by J. Aderer, Inc. for the device "SR-ISOCETTE". The FDA issued a decision of Substantially Equivalent on July 15, 1981. The device falls under product code ELK (Teeth, Artificial, Backing And Facing), a Class I device regulated under 21 CFR 872.3910. J. Aderer, Inc. has at least 10 other 510(k) clearances on record.

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.

  • K822956 — G CAST (October 26, 1982)
  • K822957 — PURCAST (October 26, 1982)
  • K821798 — 82 ALLOY (July 13, 1982)
  • K821832 — DEGUCAST U (July 6, 1982)
  • K821572 — DUALLOR 'R' (June 14, 1982)
  • K821590 — PORS-ON (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)

FDA data resources