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510(k) K110888

ABSOLUTE WHITE LIGHT by Dr. Fresh, Inc. — Product Code EEG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2012
Date Received
March 30, 2011
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 by Dr. Fresh, Inc.

  • K111250 — DRY MOUTH MOUTHWASH (April 27, 2012)

Other clearances for product code EEG

  • K122725 — TANDA PEARL, ULTRAWYTE, PEARL (November 27, 2012)
  • K063704 — BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101 (February 20, 2007)
  • K052040 — QUICKSMILE (October 18, 2005)
  • K041392 — SONX 35 ULTRASONIC BLEACHING SYSTEM; SONIWHITE ULTRA SONIC, MODEL QUICK WHITE US (November 8, 2004)
  • K042153 — SOUTH BEACH SMILE LIGHT WHITENING SYSTEM (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)