510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K904135Substantially Equivalent

Foundation Hybrid Composite

Nulite Systems Research, Australia, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904135 is the FDA 510(k) clearance record for FOUNDATION HYBRID COMPOSITE, a class II device, cleared for Nulite Systems Research on under FDA product code EBD (Coating, Filling Material, Resin). FDA records list one 510(k) clearance for Nulite Systems Research. As of , FDA records show no recalls naming K904135.

Clearance record

Decision date
Received
(251 days to decision)
Product code
EBD Coating, Filling Material, Resin
Regulation
21 CFR 872.3310
Device class
Class II
Review panel
Dental
Applicant
Nulite Systems Research 7/ 42 Leighton Pl., Australia, AU
Third party review
No

Clearances, product code EBD

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