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510(k) K955242

TITANIUM BIRD BEAK PLIER by Sybron Dental Specialties, Inc. — Product Code JEX

K955242 is an FDA 510(k) premarket notification submitted by Sybron Dental Specialties, Inc. for the device "TITANIUM BIRD BEAK PLIER". The FDA issued a decision of Substantially Equivalent on December 1, 1995. The device falls under product code JEX (Plier, Orthodontic), a Class I device regulated under 21 CFR 872.4565. Sybron Dental Specialties, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 1995
Date Received
November 15, 1995
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 Sybron Dental Specialties, Inc.

  • K182826 — Ormco Spark Aligner System (October 11, 2018)
  • K162063 — Steri-Cassette and Steri-Cage Sterilization Packaging System (April 21, 2017)
  • K160097 — Image Fast Set, Image Regular Set (August 5, 2016)
  • K153067 — Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress (July 27, 2016)
  • K152956 — Pulp Canal Sealer, Pulp Canal Sealer EWT (May 6, 2016)
  • K152959 — Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes (April 14, 2016)
  • K151526 — Zone, ZoneFree, Zone A1 (September 10, 2015)
  • K151332 — Nexus Universal, Nexus Universal Chroma (August 17, 2015)
  • K150559 — Life Fast Set, Life Regular Set (June 19, 2015)
  • K143209 — SonicFill 2 (February 5, 2015)

Other clearances for product code JEX

  • 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)
  • K760984 — ORTHODONTIC INSTRUMENTS (November 15, 1976)

FDA data resources