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510(k) K964810

DERMADAM by Ultradent Products, Inc. — Product Code EFS

K964810 is an FDA 510(k) premarket notification submitted by Ultradent Products, Inc. for the device "DERMADAM". The FDA issued a decision of Substantially Equivalent on February 10, 1997. The device falls under product code EFS (Unit, Oral Irrigation), a Class I device regulated under 21 CFR 872.6510. Ultradent Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1997
Date Received
November 29, 1996
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 Ultradent Products, Inc.

  • K262228 — Transcend Bulk Fill Flowable Composite (July 1, 2026)
  • K261404 — UltraEZ (April 30, 2026)
  • K240743 — Peak Universal Bond (March 20, 2024)
  • K240694 — FORMA Composite (Shade A3D) (March 15, 2024)
  • K221909 — J-Temp (July 1, 2022)
  • K220471 — VALO X, VALO X Accessory Lenses (February 22, 2022)
  • K211905 — UltraCal XS (October 13, 2021)
  • K211237 — UltraTemp Rez II (July 13, 2021)
  • K210550 — VALO Grand Corded and Accessory Lenses (March 1, 2021)
  • K190627 — VALO Grand Corded (April 29, 2019)

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)
  • 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)
  • K922307 — SHOWERFLOSS ORAL IRRIGATION UNIT (June 16, 1992)

FDA data resources