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510(k) K821444

COLORED WEDGE USED TO SEPARATE TEETH by Moyco Industries, Inc. — Product Code DZN

K821444 is an FDA 510(k) premarket notification submitted by Moyco Industries, Inc. for the device "COLORED WEDGE USED TO SEPARATE TEETH". The FDA issued a decision of Substantially Equivalent on June 14, 1982. The device falls under product code DZN (Instruments, Dental Hand), a Class I device regulated under 21 CFR 872.4565. Moyco Industries, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1982
Date Received
May 14, 1982
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 Moyco Industries, Inc.

  • K932511 — SILICONE MIRROR (November 5, 1993)
  • K833558 — X-RAY SHIELD (January 13, 1984)
  • K821629 — FIXIDENT (June 14, 1982)
  • K810839 — SPOTAR (April 29, 1981)
  • K810912 — ALLOY COMPOSITE POLISH (April 23, 1981)

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)
  • K801142 — PALODENT MATRICES & BITINE RINGS (August 7, 1980)
  • K801530 — COREFORM MOLDS (July 28, 1980)
  • K790555 — HEMO-WEDGE (January 17, 1980)

FDA data resources