510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K141504Substantially Equivalent

T-8000 Therozone Unit

Therozone USA, Inc., Santa Monica CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K141504 is the FDA 510(k) clearance record for T-8000 THEROZONE UNIT, a class I device, cleared for Therozone USA, Inc. on under FDA product code EIA (Unit, Operative Dental). FDA records list one 510(k) clearance for Therozone USA, Inc. As of , FDA records show no recalls naming K141504.

Clearance record

Decision date
Received
(263 days to decision)
Product code
EIA Unit, Operative Dental
Regulation
21 CFR 872.6640
Device class
Class I
Review panel
Dental
Applicant
Therozone USA, Inc. 2701 Ocean Park Blvd., Suite 108, Santa Monica CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EIA

Trailing 12 months
2 clearances under product code EIA in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code EIA, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260