510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K925088Substantially Equivalent

Expansion Screws

Forestadent, Germany, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K925088 is the FDA 510(k) clearance record for EXPANSION SCREWS, a class I device, cleared for Forestadent on under FDA product code DYJ (Retainer, Screw Expansion, Orthodontic). FDA records list 2 510(k) clearances for Forestadent, from to . As of , FDA records show no recalls naming K925088.

Clearance record

Decision date
Received
(227 days to decision)
Product code
DYJ Retainer, Screw Expansion, Orthodontic
Regulation
21 CFR 872.5410
Device class
Class I
Review panel
Dental
Applicant
Forestadent 7530 Pforzheim Westliche 151, Germany, DE
510(k) summary
Statement
Third party review
No

Clearances, product code DYJ

Trailing 12 months

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

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