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510(k) K780211

4-IN-1 DISP. CROWN & BRIDGE TRAY by Kerr Corporation (Danbury) — Product Code EHY

K780211 is an FDA 510(k) premarket notification submitted by Kerr Corporation (Danbury) for the device "4-IN-1 DISP. CROWN & BRIDGE TRAY". The FDA issued a decision of Substantially Equivalent on February 16, 1978. The device falls under product code EHY (Tray, Impression, Preformed), a Class I device regulated under 21 CFR 872.6880. Kerr Corporation (Danbury) has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1978
Date Received
February 8, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Impression, Preformed
Device Class
Class I
Regulation Number
872.6880
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)
  • K940513 — OPTIBOND (April 15, 1994)
  • K935535 — TYTIN (March 11, 1994)
  • K934690 — KERR OPTIBOND, MODIFICATION (December 30, 1993)
  • K923546 — OPTIBOND (September 29, 1992)
  • K915847 — AUTOMIX DENTAL AMALGAMATOR (March 2, 1992)

Other clearances for product code EHY

  • K942668 — O-TRAY IMPRESSION TRAYS (July 22, 1994)
  • K896470 — EOS IMPRESSION TRAYS (February 9, 1990)
  • K884316 — OCCLUSAL HARMONY IMPRESSION TRAY (December 22, 1988)
  • K863836 — POST TRAY (October 14, 1986)
  • K850776 — PREFORMED DENTAL IMPRESSION TRAYS (March 18, 1985)
  • K842274 — F-G-P TRAY (July 31, 1984)
  • K842273 — CROWN INDEX TRAY (July 31, 1984)
  • K841491 — CONVENTIONAL PLASTIC DENTAL TRAYS (July 13, 1984)
  • K841323 — FUZZY TRAY (June 27, 1984)
  • K833485 — IMPRESSION TUBE ADJUSTABLE (December 26, 1983)

FDA data resources