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510(k) K060691

EASY X-TRAC SYSTEM by A. Titan Instruments, Inc. — Product Code EMG

K060691 is an FDA 510(k) premarket notification submitted by A. Titan Instruments, Inc. for the device "EASY X-TRAC SYSTEM". The FDA issued a decision of Substantially Equivalent on June 12, 2006. The device falls under product code EMG (Forceps, Tooth Extractor, Surgical), a Class I device regulated under 21 CFR 872.4565.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2006
Date Received
March 15, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Tooth Extractor, Surgical
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances for product code EMG

  • K062130 — MEISINGER BENEX, MODEL BE001 (April 16, 2007)
  • K851708 — 500/1 TO 500/80 VARIOUS TYPES OF ENGLISH PAT DENTA (July 1, 1985)
  • K851712 — 600/203 TO 650/74XN VARIOUS TYPES OF DENT EXTRACTI (June 11, 1985)
  • K851709 — 560 TO 577 VARIOUS TYPES OF FORCEPS FOR CHILDREN (June 11, 1985)
  • K851711 — 600/7 TO 600/288 VARIOUS TYPES OF AMER. PATTERN DE (June 11, 1985)
  • K851105 — TOOTH EXTRACTING FORCEPS 151(2010)-875 PCS. SS410/ (May 15, 1985)
  • K840312 — CAT. 8 DENTAL DEVICES (April 5, 1984)
  • K823325 — DENTAL INSTRUMENTS - SURGICAL FORCEPS (November 24, 1982)
  • K821781 — BEACH FORCEP NO. 150 AND NO. 151 (July 2, 1982)

FDA data resources