Home / 510(k) Clearances / K063704

510(k) K063704

BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101 by Beks Incorporated — Product Code EEG

K063704 is an FDA 510(k) premarket notification submitted by Beks Incorporated for the device "BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101". The FDA issued a decision of Substantially Equivalent on February 20, 2007. The device falls under product code EEG (Heat Source For Bleaching Teeth), a Class I device regulated under 21 CFR 872.6475.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2007
Date Received
December 13, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Heat Source For Bleaching Teeth
Device Class
Class I
Regulation Number
872.6475
Review Panel
DE
Submission Type

Other clearances for product code EEG

  • K122725 — TANDA PEARL, ULTRAWYTE, PEARL (November 27, 2012)
  • K110888 — ABSOLUTE WHITE LIGHT (January 12, 2012)
  • K052040 — QUICKSMILE (October 18, 2005)
  • K042153 — SOUTH BEACH SMILE LIGHT WHITENING SYSTEM (November 8, 2004)
  • K041392 — SONX 35 ULTRASONIC BLEACHING SYSTEM; SONIWHITE ULTRA SONIC, MODEL QUICK WHITE US (November 8, 2004)
  • K895174 — UNION BROACH BLEACHING LIGHT (April 13, 1990)
  • K884937 — BEEHIVE-64 OR BEEHIVE-32, DIGITAL EEG RECORDING (April 14, 1989)
  • K862385 — SCHEIN BLEACHING UNIT (October 30, 1986)
  • K854692 — MONARCH II BLEACHING INSTRUMENT (May 12, 1986)
  • K832179 — HOT PROBE MODEL 6001 (October 4, 1983)

FDA data resources