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510(k) K932990

ORAL-B DISPOSABLE PROPHY ANGLE W/PROPHY CUP by Oral-B Laboratories — Product Code EFB

K932990 is an FDA 510(k) premarket notification submitted by Oral-B Laboratories for the device "ORAL-B DISPOSABLE PROPHY ANGLE W/PROPHY CUP". The FDA issued a decision of Substantially Equivalent on September 29, 1993. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. Oral-B Laboratories has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1993
Date Received
June 18, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Air-Powered, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

Other clearances by Oral-B Laboratories

  • K943157 — ORAL-B ULTRAFLOSS WITH FLLUORIDE (April 27, 1995)
  • K942633 — ORAL-B INTERDENTAL WOODSTICKS WITH FLUORIDE (April 27, 1995)
  • K943182 — ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR (September 9, 1994)
  • 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 EFB

  • K251388 — Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES (January 12, 2026)
  • K251389 — High speed air turbine handpiece (January 12, 2026)
  • K242179 — Synea Fusion Handpieces (Intensiv & Profin) (February 28, 2025)
  • K240337 — Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, (November 13, 2024)
  • K241074 — High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dent (November 12, 2024)
  • K241880 — Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing Sys (September 20, 2024)
  • K233122 — High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L, (April 30, 2024)
  • K233308 — Air Motor (Model name: FX204 M4); Air Motor (Model name: M205) (April 25, 2024)
  • K220179 — High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Ai (September 22, 2023)
  • K232243 — EVO 700 series high speed handpiece (August 23, 2023)

FDA data resources