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510(k) K771119

PASTES, RESTORATIVE & TINTED, DEBTAL by Espe Dental Products — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 1977
Date Received
June 22, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
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)
  • K800031 — PERMADYNE POLYETHER RUBBER IMPRESSION (February 5, 1980)
  • K771901 — CAPMIX (October 20, 1977)
  • K771889 — UNIOLITE (October 20, 1977)
  • K771120 — IMPREFLEX ALGINATE IMPRESSION MATERIAL (August 3, 1977)

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