Orosphere Hcdp

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K890681 ↗

FDA Product Code

EJJ

Device Class

Class II

Regulation

21 CFR Part 872.3070

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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See all devices from Jeneric/Pentron, Inc. →

• What is the OROSPHERE HCDP device used for?

  The OROSPHERE HCDP is a dental alloy amalgam device supplied as a dental restorative material for use in dental applications, specifically for restoring tooth structure after decay removal.

• How is the OROSPHERE HCDP device supplied and is it reusable?

  The OROSPHERE HCDP is supplied as a dental restorative material, typically in pre-proportioned capsules or triturated form for chairside use; it is intended for single-use per restoration and not designed for reuse due to contamination risk and material degradation after placement.

• What regulatory pathway was used for the OROSPHERE HCDP device?

  The OROSPHERE HCDP received traditional 510(k) clearance (K890681) from the FDA on May 2, 1989, demonstrating substantial equivalence to a legally marketed predicate device under regulation number 872.3070 for dental alloy amalgam.