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510(k) K840984

INTERDENTAL WEDGES by Healthco, Inc. — Product Code DZN

K840984 is an FDA 510(k) premarket notification submitted by Healthco, Inc. for the device "INTERDENTAL WEDGES". The FDA issued a decision of Substantially Equivalent on April 13, 1984. The device falls under product code DZN (Instruments, Dental Hand), a Class I device regulated under 21 CFR 872.4565. Healthco, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 1984
Date Received
March 6, 1984
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 Healthco, Inc.

  • K823133 — AIR FLOW I (November 17, 1982)
  • K823134 — AIR FLOW II (November 17, 1982)
  • K821810 — PIEZON ULTRASONIC SCALER (July 6, 1982)

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)
  • 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)
  • K801530 — COREFORM MOLDS (July 28, 1980)
  • K790555 — HEMO-WEDGE (January 17, 1980)

FDA data resources