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510(k) K910303

SYSNPAR PORCELAIN by Jeneric/Pentron, Inc. — Product Code ELL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 1991
Date Received
January 24, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Teeth, Porcelain
Device Class
Class II
Regulation Number
872.3920
Review Panel
DE
Submission Type

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  • K010957 — QUELL DESENSITIZER (June 25, 2001)
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  • K011331 — JP CAST 40 (June 22, 2001)
  • K011362 — GOLD CORE 73 LS (May 29, 2001)
  • K010044 — COSMIC (February 9, 2001)

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  • K032562 — PROCEARA COPINGS AND PONTIC (February 6, 2004)
  • K965216 — ARGI-SATIN OR OPTI0-STAR (February 27, 1997)
  • K960770 — MATCHMAKER/PROPAQUE PORCELAIN (November 19, 1996)