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510(k) K042153

SOUTH BEACH SMILE LIGHT WHITENING SYSTEM by Dentovations, Inc. — Product Code EEG

K042153 is an FDA 510(k) premarket notification submitted by Dentovations, Inc. for the device "SOUTH BEACH SMILE LIGHT WHITENING SYSTEM". The FDA issued a decision of Substantially Equivalent on November 8, 2004. 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
November 8, 2004
Date Received
August 9, 2004
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)
  • 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)
  • 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