510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964810Substantially Equivalent

Dermadam

Ultradent Products Inc., South Jordan UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964810 is the FDA 510(k) clearance record for DERMADAM, a class I device, cleared for Ultradent Products, Inc. on under FDA product code EFS (Unit, Oral Irrigation). FDA records list 104 510(k) clearances for Ultradent Products, Inc., from to . As of , FDA records show no recalls naming K964810.

Clearance record

Decision date
Received
(73 days to decision)
Product code
EFS Unit, Oral Irrigation
Regulation
21 CFR 872.6510
Device class
Class I
Review panel
Dental
Applicant
Ultradent Products, Inc. 505 W. 10200 S., South Jordan UT
510(k) summary
Statement
Third party review
No

Clearances, product code EFS

Trailing 12 months

FDA records hold no clearances under product code EFS in the trailing twelve months.

FDA records show no clearances under product code EFS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EFS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260