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510(k) K031721

COMPOSITE RESTORATION MATERIAL by Milton Hodosh, M.D. — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2003
Date Received
June 3, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
Review Panel
DE
Submission Type

Other clearances by Milton Hodosh, M.D.

  • K032175 — DESENS-IONOMER (October 9, 2003)
  • K022025 — MODIFICATION TO POTASSIUM NITRATE-POLYCARBOXYLATE DENTAL CEMENT (August 15, 2002)
  • K925207 — GLASS IONOMER CEMENT (July 8, 1993)
  • K905582 — POTASSIUM NITRATE COMPOSITE RESTORATION PIT AND (April 29, 1991)
  • K895988 — POTASSIUM NITRATE-ZINC OXIDE EUGENOL TEMP. DENTAL (March 7, 1990)
  • K882417 — POTASSIUM NITRATE POLYCARBOXYLATE DENTAL CEMENT (February 13, 1989)

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