Foundation Hybrid Composite

FDA 510(k) K904135 · Nulite Systems Research

Substantially Equivalent

510(k) numberK904135

Submission

Device name
Foundation Hybrid Composite
Applicant
Nulite Systems Research
Australia, AU
Received
September 6, 1990
Decision date
May 15, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EBD – Coating, Filling Material, Resin
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3310
Specialty
Dental

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Questions and answers

When was Foundation Hybrid Composite cleared by the FDA?

Foundation Hybrid Composite (K904135) received a 510(k) decision of Substantially Equivalent on May 15, 1991, 251 days after the submission was received.

What is the product code of K904135?

The FDA product code is EBD – Coating, Filling Material, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3310.