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510(k) K771889

UNIOLITE by Espe Dental Products — Product Code EBZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1977
Date Received
October 6, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Activator, Ultraviolet, For Polymerization
Device Class
Class II
Regulation Number
872.6070
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)
  • K771120 — IMPREFLEX ALGINATE IMPRESSION MATERIAL (August 3, 1977)
  • K771119 — PASTES, RESTORATIVE & TINTED, DEBTAL (July 15, 1977)

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