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510(k) K023046

SST SALIVA SUPPORTING TABLETS by Sinclair Pharmaceuticals, Ltd. — Product Code LED

K023046 is an FDA 510(k) premarket notification submitted by Sinclair Pharmaceuticals, Ltd. for the device "SST SALIVA SUPPORTING TABLETS". The FDA issued a decision of Substantially Equivalent on December 2, 2002. The device falls under product code LED (Stains, Chemical Solution), a Class I device regulated under 21 CFR 864.1850. Sinclair Pharmaceuticals, Ltd. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 2002
Date Received
September 12, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stains, Chemical Solution
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
Submission Type

Other clearances by Sinclair Pharmaceuticals, Ltd.

  • K050158 — SINCLAIR SEBORRHEA EMULSION (October 11, 2006)
  • K042722 — ALOCLAIR ORAL SPRAY (January 13, 2005)
  • K040950 — ALOCLAIR ORAL GEL (June 21, 2004)
  • K024148 — SALINUM, ORCLAIR (September 15, 2003)
  • K024367 — SINCLAIR WOUND AND SKIN EMULSION (July 28, 2003)
  • K023155 — ALOCLAIR ORAL RINSE (November 25, 2002)
  • K013056 — GELCLAIR CONCENTRATED ORAL GEL (December 21, 2001)

Other clearances for product code LED

  • K051409 — SLIVASURE (August 8, 2005)
  • K860795 — SPOTTEST CALCOFLUOR WHITE REAGENT (March 12, 1986)
  • K860319 — MEGACOLOR (February 20, 1986)
  • K860316 — PANOPTIKON (February 20, 1986)
  • K860321 — LYSOCOLOR (February 20, 1986)
  • K860317 — NEUTROCOLOR (February 20, 1986)
  • K860320 — GRANULOCOLOR (February 20, 1986)
  • K854176 — POLYCHROME IV STAIN (October 31, 1985)
  • K851481 — SPOTTEST IODINE SOLUTION DOBELL & O'CONNOR (April 29, 1985)
  • K842930 — GOMORI'S TRICHROME STAIN (September 11, 1984)

FDA data resources