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510(k) K960770

MATCHMAKER/PROPAQUE PORCELAIN by Davis Schottlander & Davis, Ltd. — Product Code ELL

K960770 is an FDA 510(k) premarket notification submitted by Davis Schottlander & Davis, Ltd. for the device "MATCHMAKER/PROPAQUE PORCELAIN". The FDA issued a decision of Substantially Equivalent on November 19, 1996. The device falls under product code ELL (Teeth, Porcelain), a Class II device regulated under 21 CFR 872.3920. Davis Schottlander & Davis, Ltd. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1996
Date Received
February 26, 1996
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 Davis Schottlander & Davis, Ltd.

  • K024252 — MATCH MASTER LOW FUSION PORCELAIN (January 22, 2004)
  • K024250 — MATCH PRESS PRESSABLE CERAMIC (August 25, 2003)
  • K001463 — SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156 (June 16, 2000)
  • K993717 — ENIGMA HI-BASE DENTURE BASE MATERIAL (December 22, 1999)
  • K984134 — NATURA DENTURE TEETH (February 12, 1999)
  • K984128 — ENIGMA DENTURE TEETH (February 9, 1999)

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)
  • K960480 — IN-CERAM SPINELL KIT FOR CELAV MODEL V56-001/E63013 (March 15, 1996)

FDA data resources