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510(k) K801484

ROOT CANAL FILLING APPLICATOR NEEDLES by National Patent Development Corp. — Product Code EIC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1980
Date Received
May 16, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Periodontic, Endodontic, Irrigating
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

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  • K820006 — ZEON COMPOSITE RESIN SYSTEM (January 22, 1982)
  • K811446 — HYDRON WOUND DRESSING KIT (June 12, 1981)
  • K801482 — HYDRON ROOT CANAL FILLING MATERIAL (July 21, 1980)
  • K801483 — MARK IV SYRINGE (July 21, 1980)
  • K792136 — HYPO-ALLERGENIC PLASTIC TAPE (January 16, 1980)
  • K792227 — MULTI-AD FLUID DISPENSING SYSTEM (December 20, 1979)

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  • K811889 — R & S SERIES FITTING TOOLS (July 24, 1981)
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  • K801483 — MARK IV SYRINGE (July 21, 1980)
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  • K792577 — ENDOVAGE SYRINGE (January 4, 1980)