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510(k) K874025

2ND MODIFIED VINYLAC PRESS PACK DENTURE RESIN by Astron Dental Corp. — Product Code EBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 1987
Date Received
October 2, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resin, Denture, Relining, Repairing, Rebasing
Device Class
Class II
Regulation Number
872.3760
Review Panel
DE
Submission Type

Other clearances by Astron Dental Corp.

  • K864757 — MODIFIED VINYLAC PRESS PACK DENTURE RESIN (February 10, 1987)
  • K852906 — DURACLEAN DENTURE CLEANER (July 31, 1985)
  • K833270 — ASTRON 77 INJECTION DENTURE RESIN (July 19, 1984)
  • K831269 — VINYLAC PRESS-PACK DENTURE RESIN (June 8, 1983)

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