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510(k) K901600

OSSEOTITE IRRIGATION UNIT by Collagen Corp. — Product Code EFS

K901600 is an FDA 510(k) premarket notification submitted by Collagen Corp. for the device "OSSEOTITE IRRIGATION UNIT". The FDA issued a decision of Substantially Equivalent on June 21, 1990. The device falls under product code EFS (Unit, Oral Irrigation), a Class I device regulated under 21 CFR 872.6510. Collagen Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1990
Date Received
April 6, 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 Collagen Corp.

  • K904671 — QAR HANDPIECE (December 21, 1990)
  • K904228 — OSSEODENT DENTAL ATTACHMENTS (NON-ANGLED) (November 9, 1990)
  • K900275 — OSSEODENT DENTAL ATTACHMENT, IGLOO MAGNET (April 19, 1990)
  • K895462 — OSSEODENT DENTAL ATTACHMENTS (April 4, 1990)
  • K895463 — OSSEODENT(R) PRECISION DENTAL ATTACHMENTS (March 28, 1990)
  • K894331 — OSSEODENT SURGICAL KIT (October 4, 1989)
  • K883322 — DENTAL HAND INSTRUMENTS (August 26, 1988)
  • K812617 — VITROGEN TM 100 (October 2, 1981)

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