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510(k) K895174

UNION BROACH BLEACHING LIGHT by Union Broach, Div. Moyco Industries, Inc. — Product Code EEG

K895174 is an FDA 510(k) premarket notification submitted by Union Broach, Div. Moyco Industries, Inc. for the device "UNION BROACH BLEACHING LIGHT". The FDA issued a decision of Substantially Equivalent on April 13, 1990. The device falls under product code EEG (Heat Source For Bleaching Teeth), a Class I device regulated under 21 CFR 872.6475. Union Broach, Div. Moyco Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 1990
Date Received
August 7, 1989
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 Union Broach, Div. Moyco Industries, Inc.

  • K962733 — CYBER-FIL ALKENOATE CEMENT MULTI-PURPOSE KIT (23900/23905/23910/23915/23920) (October 11, 1996)
  • K950365 — MOYCO-EDTA (April 27, 1995)
  • K941574 — RETRO MIRROR (May 18, 1994)
  • K940260 — THERMAL PULP TESTER (March 7, 1994)
  • K935542 — NICKEL-TITANIUM K-TYPE FILE (January 3, 1994)
  • K931742 — INJECT-R FILL (May 27, 1993)
  • K923661 — QUADRASORB FILTER (October 20, 1992)
  • K855136 — FLEXOR FLEXIBLE ROANE TIP ENDODONTIC FILE (March 6, 1986)
  • K852474 — UNION BROACH BLEACHING LIGHT (July 1, 1985)
  • K823489 — ENDODONTIC BROACH-BARBED BROACH (December 15, 1982)

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)
  • 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)
  • 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