Home / 510(k) Clearances / K942633

510(k) K942633

ORAL-B INTERDENTAL WOODSTICKS WITH FLUORIDE by Oral-B Laboratories — Product Code JET

K942633 is an FDA 510(k) premarket notification submitted by Oral-B Laboratories for the device "ORAL-B INTERDENTAL WOODSTICKS WITH FLUORIDE". The FDA issued a decision of Substantially Equivalent on April 27, 1995. The device falls under product code JET (Pick, Massaging), a Class I device regulated under 21 CFR 872.6650. Oral-B Laboratories has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 1995
Date Received
June 3, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pick, Massaging
Device Class
Class I
Regulation Number
872.6650
Review Panel
DE
Submission Type

Other clearances by Oral-B Laboratories

  • K943157 — ORAL-B ULTRAFLOSS WITH FLLUORIDE (April 27, 1995)
  • K943182 — ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR (September 9, 1994)
  • K932990 — ORAL-B DISPOSABLE PROPHY ANGLE W/PROPHY CUP (September 29, 1993)
  • K925409 — ORAL-B DENTAL FLOSS WITH FLUORIDE (January 28, 1993)
  • K925408 — ORAL-B DENTAL TAPE WITH FLUORIDE (January 28, 1993)
  • K913603 — FIBRETWINS (September 30, 1991)
  • K883024 — ORAL-B FLOSSERS (August 26, 1988)

Other clearances for product code JET

  • K963747 — REACH STIM-U-DENT PLAQUE REMOVERS WITH MICRODENT/REACH FLOSS STIKS WITH MICRODEN (December 16, 1996)
  • K930178 — ELECTRO FLOSS (July 28, 1993)
  • K911418 — GUM MASSAGER (July 17, 1991)
  • K885189 — MASSAGING PICK FOR ORAL HYGIENE (March 17, 1989)
  • K890910 — PLAKOF (March 16, 1989)
  • K883225 — FLOSSIE (August 30, 1988)
  • K881900 — PERMA-PIC PLASTIC TOOTHPICK (June 1, 1988)
  • K881046 — SUPER PIK MASSAGING PICK FOR ORAL HYGIENE (May 13, 1988)
  • K860779 — ULTRAPROX, INTERPROXIMAL TOOTHBRUSH (April 2, 1986)
  • K850775 — DENTAL MASSAGING PICKS (April 10, 1985)

FDA data resources