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510(k) K924821

MICRODOSE PORCELAIN ETCHANT by Unicep — Product Code ELL

K924821 is an FDA 510(k) premarket notification submitted by Unicep for the device "MICRODOSE PORCELAIN ETCHANT". The FDA issued a decision of Substantially Equivalent on March 16, 1993. The device falls under product code ELL (Teeth, Porcelain), a Class II device regulated under 21 CFR 872.3920. Unicep has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1993
Date Received
September 28, 1992
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

Other clearances by Unicep

  • K925163 — MICODOSE CHLORHEXIPREP (May 27, 1993)
  • K924823 — MICRODOSE SILANE (March 16, 1993)
  • K925162 — MICRODOSE DENTIN CONDITIONER (March 16, 1993)
  • K924824 — MICRODOSE PIT AND FISSURE SEALANT-CLEAR OR WHITE (March 16, 1993)
  • K924822 — MICRODOSE ENAMEL ETCHANT (March 5, 1993)
  • K924827 — MICRODOSE POTASSIUM OXYLATE (March 5, 1993)
  • K924826 — MICRODOSE TOTAL ETCHANT (March 5, 1993)
  • K924825 — MICRODOSE RC-EZ (March 5, 1993)

Other clearances for product code ELL

  • K240586 — Additive Manufacturing Zirconia Customized Restoration (October 3, 2024)
  • K203072 — Franz Zirconia Dental Crown (January 19, 2022)
  • K162043 — NobelProcera HT ML FCZ Bridge (November 22, 2016)
  • K153534 — NobelProcera HT ML Full Contour Zirconia Crown (June 6, 2016)
  • K071182 — PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013 (July 11, 2007)
  • K060530 — SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING F (May 22, 2006)
  • K041283 — PROCERA BRIDGE ZIRCONIA (May 28, 2004)
  • K032562 — PROCEARA COPINGS AND PONTIC (February 6, 2004)
  • K965216 — ARGI-SATIN OR OPTI0-STAR (February 27, 1997)
  • K960770 — MATCHMAKER/PROPAQUE PORCELAIN (November 19, 1996)

FDA data resources