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510(k) K930336

PROFAST(R)-DENTURE ADHESIVE CREAM by Fittydent-Altwirth & Schmitt GmbH — Product Code KGB

K930336 is an FDA 510(k) premarket notification submitted by Fittydent-Altwirth & Schmitt GmbH for the device "PROFAST(R)-DENTURE ADHESIVE CREAM". The FDA issued a decision of Substantially Equivalent on August 24, 1993. The device falls under product code KGB (Mask, Oxygen, Non-Rebreathing), a Class I device regulated under 21 CFR 868.5570. Fittydent-Altwirth & Schmitt GmbH has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 1993
Date Received
January 22, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Oxygen, Non-Rebreathing
Device Class
Class I
Regulation Number
868.5570
Review Panel
AN
Submission Type

Other clearances by Fittydent-Altwirth & Schmitt GmbH

  • K930335 — PROFAST - DENTURE ADHESIVE FOR LOWER JAWS (February 1, 1994)
  • K930337 — PROFAST(R)-DENTURE CLEANSER (September 7, 1993)

Other clearances for product code KGB

  • K970688 — POCKET RESCUE (September 26, 1997)
  • K960401 — ULTIMATE SEAL (June 20, 1996)
  • K941336 — COMBO MASK (September 9, 1994)
  • K935917 — CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVES (February 4, 1994)
  • K932347 — COMPACT MASK (January 10, 1994)
  • K933583 — NONREBREATHING VALVE (January 3, 1994)
  • K933048 — LAERDAL(TM) POCKET MASK, MODIFICATION (December 2, 1993)
  • K913164 — NON REBREATHING MASK (January 15, 1992)
  • K883766 — MOUTH-TO-MASK VENTILATORY ADJUNCT (October 21, 1988)
  • K790161 — OXYGEN MASK W/RESERVOIR BAG (April 20, 1979)

FDA data resources