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510(k) K940513

OPTIBOND by Kerr Corporation (Danbury) — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1994
Date Received
February 4, 1994
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)
  • K935535 — TYTIN (March 11, 1994)
  • K934690 — KERR OPTIBOND, MODIFICATION (December 30, 1993)
  • K923546 — OPTIBOND (September 29, 1992)
  • K915847 — AUTOMIX DENTAL AMALGAMATOR (March 2, 1992)
  • K904756 — MATRICS (March 15, 1991)

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