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510(k) K800031

PERMADYNE POLYETHER RUBBER IMPRESSION by Espe Dental Products — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1980
Date Received
January 7, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Impression
Device Class
Class II
Regulation Number
872.3660
Review Panel
DE
Submission Type

Other clearances by Espe Dental Products

  • K810950 — VISIO-SEAL (April 29, 1981)
  • K802819 — KETAC-CEM IN REF. TO K802048 (November 24, 1980)
  • K802049 — NIMETIC-DISPERS (September 16, 1980)
  • K771901 — CAPMIX (October 20, 1977)
  • K771889 — UNIOLITE (October 20, 1977)
  • K771120 — IMPREFLEX ALGINATE IMPRESSION MATERIAL (August 3, 1977)
  • K771119 — PASTES, RESTORATIVE & TINTED, DEBTAL (July 15, 1977)

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