Home / 510(k) Clearances / K780460

510(k) K780460

DENTAL AIR BRUSH by M. Joel Gebhart, D.D.S. — Product Code KOH

K780460 is an FDA 510(k) premarket notification submitted by M. Joel Gebhart, D.D.S. for the device "DENTAL AIR BRUSH". The FDA issued a decision of Substantially Equivalent on June 28, 1978. The device falls under product code KOH (Instrument, Manual, General Obstetric-Gynecologic), a Class I device regulated under 21 CFR 884.4520.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1978
Date Received
March 22, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Manual, General Obstetric-Gynecologic
Device Class
Class I
Regulation Number
884.4520
Review Panel
OB
Submission Type

Other clearances for product code KOH

  • K000212 — KSEA CHARDONNES MORCELLATION KNIFE (April 21, 2000)
  • K921730 — C-SECTION PACK (June 15, 1994)
  • K921732 — MINOR LAP SET (June 15, 1994)
  • K891351 — NEWPORT LATERAL VAGINAL RETRACTOR (May 11, 1989)
  • K892693 — VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT (May 11, 1989)
  • K891035 — NEEDLE EXTENSIONS (March 22, 1989)
  • K891049 — ZEPPELIN SCISSORS (March 17, 1989)
  • K863610 — THE OB-GYN CONCEPTS VAGINAL ASPIRATOR (January 7, 1987)
  • K840308 — CAT. 4-OBSTETRICS GYNECOLOGY DEV'S (March 5, 1984)
  • K823792 — QUARTZ RETRACTOR/PROBE (January 18, 1983)

FDA data resources