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510(k) K884220

AIR WATER SYRINGE TIP SHIELD by Steri-Shield Products, Inc. — Product Code EFS

K884220 is an FDA 510(k) premarket notification submitted by Steri-Shield Products, Inc. for the device "AIR WATER SYRINGE TIP SHIELD". The FDA issued a decision of Substantially Equivalent on March 17, 1989. The device falls under product code EFS (Unit, Oral Irrigation), a Class I device regulated under 21 CFR 872.6510. Steri-Shield Products, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1989
Date Received
October 6, 1988
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 Steri-Shield Products, Inc.

  • K884223 — DENTAL LAMP HANDLE COVER (March 17, 1989)
  • K884222 — CURING LIGHT COVER (March 17, 1989)
  • K884221 — ULTRASONIC SCALER COVER (March 17, 1989)
  • K884219 — BRACKET TABLE ARM COVER (March 17, 1989)

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