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510(k) K830491

JOHNSON & JOHNSON OPAQUE COLOR MODIFI by Johnson & Johnson Professionals, Inc. — Product Code EBE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1983
Date Received
February 15, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coating, Denture Hydrophilic, Resin
Device Class
Class II
Regulation Number
872.3300
Review Panel
DE
Submission Type

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Other clearances for product code EBE

  • K832500 — CS-11 (October 27, 1983)
  • K790339 — CONCEPT II (July 17, 1979)