Home / 510(k) Clearances / K945200

510(k) K945200

FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCES by Procter & Gamble Co. — Product Code KOO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 1994
Date Received
October 25, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt
Device Class
Class I
Regulation Number
872.3490
Review Panel
DE
Submission Type

Other clearances by Procter & Gamble Co.

  • K203567 — Oral-B Dry Mouth Oral Rinse (April 5, 2021)
  • K201277 — Oral-B Dry Mouth Oral Rinse (September 2, 2020)
  • K200881 — Oral-B iO Test Drive Power Brush Trial Program Kit (August 27, 2020)
  • K151413 — Always/Tampax bladder supports (December 18, 2015)
  • K141018 — ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBR (September 15, 2014)
  • K133244 — TAMPAX M PLASTIC TAMPONS, UNSCENTED (January 9, 2014)
  • K131543 — TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED (June 20, 2013)
  • K113699 — TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED (January 12, 2012)
  • K110669 — TAMPAX C PLASTIC TAMPONS, UNSCENTED (June 2, 2011)
  • K091281 — TAMPAX PEARL UNSCENTED TAMPONS, LIGHT, REGULAR, SUPER & SUPER PLUS, TAMPAX PEARL (June 1, 2010)

Other clearances for product code KOO

  • K943486 — ORAFIX SPECIAL DENTURE ADHESIVE (November 3, 1994)
  • K930335 — PROFAST - DENTURE ADHESIVE FOR LOWER JAWS (February 1, 1994)
  • K862876 — NEW SUPER POLI-GRIP DENTURE ADHESIVE CREAM (August 29, 1986)