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510(k) K934690

KERR OPTIBOND, MODIFICATION by Kerr Corporation (Danbury) — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1993
Date Received
July 26, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Tooth Bonding, Resin
Device Class
Class II
Regulation Number
872.3200
Review Panel
DE
Submission Type

Other clearances by Kerr Corporation (Danbury)

  • K051545 — L.E. DEMETRON II (July 18, 2005)
  • K020091 — OPTILUX 501 (March 21, 2002)
  • K951663 — TYTIN R (June 6, 1995)
  • K951511 — TYTIN ADMIX (May 2, 1995)
  • K942480 — M4 CONTRA-ANGLE HANDPIECE (January 27, 1995)
  • K940513 — OPTIBOND (April 15, 1994)
  • K935535 — TYTIN (March 11, 1994)
  • K923546 — OPTIBOND (September 29, 1992)
  • K915847 — AUTOMIX DENTAL AMALGAMATOR (March 2, 1992)
  • K904756 — MATRICS (March 15, 1991)

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