510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K891589Substantially Equivalent

3Mm Disposable Specula

Semantodontics, Inc., Phoenix AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K891589 is the FDA 510(k) clearance record for 3MM DISPOSABLE SPECULA, a class I device, cleared for Semantodontics, Inc. on under FDA product code FXG (Specula Accessories). FDA records list one 510(k) clearance for Semantodontics, Inc. As of , FDA records show no recalls naming K891589.

Clearance record

Decision date
Received
(29 days to decision)
Product code
FXG Specula Accessories
Regulation
21 CFR 878.1800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Semantodontics, Inc. 3400 E. Mcdowell Rd., Phoenix AZ
Third party review
No

Clearances, product code FXG

Trailing 12 months

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

FDA records show no clearances under product code FXG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FXG, 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