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510(k) K760984

ORTHODONTIC INSTRUMENTS by Adp Intl., Inc. — Product Code JEX

K760984 is an FDA 510(k) premarket notification submitted by Adp Intl., Inc. for the device "ORTHODONTIC INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on November 15, 1976. The device falls under product code JEX (Plier, Orthodontic), a Class I device regulated under 21 CFR 872.4565. Adp Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 1976
Date Received
October 21, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plier, Orthodontic
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Adp Intl., Inc.

  • K760980 — DENTAL ALLOY (November 15, 1976)
  • K760986 — CARBIDE DENTAL BURS (November 15, 1976)
  • K760988 — DENTAL HANDPIECES (November 15, 1976)
  • K760978 — ZINC CEMENT (November 15, 1976)
  • K760979 — COMPOSITE MATERIAL (November 15, 1976)
  • K760987 — DIAMOND STONES (November 15, 1976)
  • K760985 — HAND INSTRUMENTS (November 15, 1976)
  • K760981 — ALGINATE IMPRESSION MATERIAL (November 15, 1976)
  • K760983 — ENDODONTIC INSTRUMENTS (November 15, 1976)
  • K760982 — DENTAL VARNISH (November 15, 1976)

Other clearances for product code JEX

  • K955242 — TITANIUM BIRD BEAK PLIER (December 1, 1995)
  • K935141 — DENTAURUM PLIERS (January 31, 1994)
  • K924645 — TRANSCEND SERIES 6000 DEBONDING INSTRUMENTS (November 25, 1992)
  • K924295 — DEBRACKETING INSTRUMENT (November 23, 1992)
  • K854088 — UNITEK LIFT-OFF DEBRACKETING INSTRUMENT (November 26, 1985)
  • K843742 — UNITEK CONVERTIBLE CAP REMOVER TOOL (November 9, 1984)

FDA data resources