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510(k) K990908

MILLENNIUM by Endo Technic Corp. — Product Code MXF

K990908 is an FDA 510(k) premarket notification submitted by Endo Technic Corp. for the device "MILLENNIUM". The FDA issued a decision of Substantially Equivalent on May 27, 1999. The device falls under product code MXF (System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation), a Class II device regulated under 21 CFR 872.4120. Endo Technic Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1999
Date Received
March 18, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation
Device Class
Class II
Regulation Number
872.4120
Review Panel
DE
Submission Type

Other clearances by Endo Technic Corp.

  • K971459 — DERMALASE (July 18, 1997)
  • K925079 — LAPAROSCOPIC INST. (SCISSORS,FORCEPS,NEEDLEHOLDER) (August 24, 1994)
  • K930756 — LAPAROSCOPIC IRRIGATION/ASPIRATION HANDPIECE (March 9, 1994)
  • K925114 — LAPAROSCOPIC INSTRUMENTS (February 28, 1994)
  • K924058 — TROCAR (March 30, 1993)
  • K914825 — 1-125 ENDOSEED (March 19, 1992)
  • K910200 — LASER-35 (May 9, 1991)
  • K864976 — SOLUSET CALCIUM DEMINERALIZING SOLUTION (February 27, 1987)
  • K862129 — SET CANAL SEALER PASTE (July 22, 1986)

Other clearances for product code MXF

  • K022803 — WATERLASE FOR APICOECTOMY (February 3, 2003)
  • K013908 — WATERLASE MILLENNIUM (February 12, 2002)
  • K012511 — WATERLASE MILLENNIUM (January 18, 2002)
  • K990219 — MODIFICATION OF MILLENNIUM (February 24, 1999)

FDA data resources