Home / 510(k) Clearances / K901955

510(k) K901955

PERIOGARD(R) PERIOPEN by Colgate-Palmolive Co. — Product Code EFS

K901955 is an FDA 510(k) premarket notification submitted by Colgate-Palmolive Co. for the device "PERIOGARD(R) PERIOPEN". The FDA issued a decision of Substantially Equivalent on April 15, 1991. The device falls under product code EFS (Unit, Oral Irrigation), a Class I device regulated under 21 CFR 872.6510. Colgate-Palmolive Co. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1991
Date Received
May 1, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Oral Irrigation
Device Class
Class I
Regulation Number
872.6510
Review Panel
DE
Submission Type

Other clearances by Colgate-Palmolive Co.

  • K140481 — COLGATE DESENSITIZING MOUTHRINSE, COLGATE SENSITIVE PRO-RELIEF MOUTHWASH (June 5, 2014)
  • K103461 — COLGATE DESENSITIZING DENTAL CREAM (September 13, 2011)
  • K944886 — COLGATE PRECISION MINT WZXED DENTAL FLOSS (April 27, 1995)
  • K883335 — COLGATE DENTAL FLOSS (August 26, 1988)

Other clearances for product code EFS

  • K023232 — SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE (December 11, 2002)
  • K001493 — DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001 (October 25, 2000)
  • K983374 — AGATHA-A-H2010 (December 23, 1998)
  • K964810 — DERMADAM (February 10, 1997)
  • K952234 — BARRIER ALL FILM (July 31, 1995)
  • K943182 — ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR (September 9, 1994)
  • K923711 — PERIOFLEX TIP (May 16, 1994)
  • K923937 — HYDRO FLOSS (February 25, 1994)
  • K931380 — WATER PIK PLUS PLAQUE CONTROL SYSTEM (September 20, 1993)
  • K923457 — SHOWERFLOSS (September 1, 1992)

FDA data resources