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510(k) K844339

BRAUN DENTAL CENTER OC-3 by The Braun Corp. — Product Code EFS

K844339 is an FDA 510(k) premarket notification submitted by The Braun Corp. for the device "BRAUN DENTAL CENTER OC-3". The FDA issued a decision of Substantially Equivalent on February 8, 1985. The device falls under product code EFS (Unit, Oral Irrigation), a Class I device regulated under 21 CFR 872.6510. The Braun Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 1985
Date Received
November 8, 1984
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 The Braun Corp.

  • K061351 — ORAL-B SONIC COMPLETE (June 5, 2006)
  • K061199 — ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES (May 31, 2006)
  • K060006 — BRAUN THERMOSCAN IRT 2000 INFRARED EAR THERMOMETER (January 31, 2006)
  • K031928 — BRAUN THERMOSCAN PRO 4000 SERIES (PROFESSIONAL USE ENVIRONMENT); BRAUN THERMOSCA (October 24, 2003)
  • K012035 — BRAUN PRECISION SENSOR PRO, MODEL BP 2590 (July 27, 2001)
  • K003732 — BRAUN PRECISION SENSOR, MODEL BP 2000 SERIES (May 16, 2001)
  • K992468 — BRAUN THERMOSCAN PRO3000 INFARED THERMOMETER (October 20, 1999)
  • K983295 — BRAUN THERMOSCAN IRT3020/3500 ONE SECONS EAR THERMOMETER, MODEL IRT3020/3520 (March 15, 1999)

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