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510(k) K110888

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

K110888 is an FDA 510(k) premarket notification submitted by Dr. Fresh, Inc. for the device "ABSOLUTE WHITE LIGHT". The FDA issued a decision of Substantially Equivalent on January 12, 2012. The device falls under product code EEG (Heat Source For Bleaching Teeth), a Class I device regulated under 21 CFR 872.6475. Dr. Fresh, Inc. has at least 1 other 510(k) clearance on record.

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)
  • 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