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510(k) K801530

COREFORM MOLDS by Sybron Corp. — Product Code DZN

K801530 is an FDA 510(k) premarket notification submitted by Sybron Corp. for the device "COREFORM MOLDS". The FDA issued a decision of Substantially Equivalent on July 28, 1980. The device falls under product code DZN (Instruments, Dental Hand), a Class I device regulated under 21 CFR 872.4565. Sybron Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1980
Date Received
July 2, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instruments, Dental Hand
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Sybron Corp.

  • K862284 — SEALITE (June 23, 1986)
  • K854855 — PROOF ALGINATE IMPRESSION MATERIAL (January 30, 1986)
  • K844092 — DIAGNOSTIC MICROSOPCE SLIDES (October 25, 1984)
  • K842132 — TYCOS SELF-CHECK/DIGITAL FEVER THERMO (July 18, 1984)
  • K841910 — KERR SEALAPEX ROOT CANAL SEALER (July 13, 1984)
  • K841732 — LIEBEL-FLARSHEIM AFC 1000 X-RAY FILM (June 5, 1984)
  • K840469 — TYCOS SELF CHECK BPM3 BLOOD PRESS MONI (May 21, 1984)
  • K840407 — KERR RESIN BONDED BRIDGE CEMENT (May 21, 1984)
  • K840607 — LF MOTORIZED RADIOGRAPHIC FILM VIEWER (March 5, 1984)
  • K833138 — DIGITAL INJECTOR SYS (November 14, 1983)

Other clearances for product code DZN

  • K111465 — COMPOTHIXO (July 25, 2012)
  • K071858 — DENTAL MATRIX BAND (August 31, 2007)
  • K901919 — CONTACT MOLAR BANDS AND CONTOUR STRIPS (June 22, 1990)
  • K861581 — CENTRIX PCR MOLAR MATRIX FORMS (BANDS) (May 12, 1986)
  • K844324 — TIGER BAND (December 3, 1984)
  • K840984 — INTERDENTAL WEDGES (April 13, 1984)
  • K822094 — DENTAL MATRIX BAND (August 16, 1982)
  • K821444 — COLORED WEDGE USED TO SEPARATE TEETH (June 14, 1982)
  • K801142 — PALODENT MATRICES & BITINE RINGS (August 7, 1980)
  • K790555 — HEMO-WEDGE (January 17, 1980)

FDA data resources