Osteograf/N Natural Hydroxylapatite, 40-60 Mesh

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

510(k) Number

K902295 ↗

FDA Product Code

LYC

Device Class

Class II

Regulation

21 CFR Part 872.3930

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K960361 Active Cleared 15 Apr 1996

• Osteograf Stainless Steel Syring

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  FDA 510(k) K962786 Active Cleared 1 Aug 1996

• Permaridge Syringe

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• Osteograf/Ld-300 Hydroxylapatite

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  FDA 510(k) K942212 Active Cleared 23 Aug 1994

• Osteograf/N-700 Natural Hydroxylapatite 18-40 Mesh

  Class II

  FDA 510(k) K921469 Active Cleared 25 Jun 1992

• Osteograft/N-700 Hydroxylaptite

  Class II

  FDA 510(k) K960368 Active Cleared 18 Apr 1996

See all devices from Ceramed Corp. →

• What is Osteograf/N Natural Hydroxyapatite used for?

  Osteograf/N Natural Hydroxyapatite is a synthetic bone graft substitute specifically designed for dental applications. It is used in dental surgical procedures as a bone grafting material to help promote bone regeneration and support in the jaw.

• How is Osteograf/N Natural Hydroxyapatite supplied?

  The device is supplied as a sterile, single-use product for implantation in dental surgical procedures. It comes in a 40-60 mesh particle size, which refers to the size of the hydroxyapatite particles.

• What is the regulatory status of Osteograf/N Natural Hydroxyapatite?

  Osteograf/N Natural Hydroxyapatite received FDA 510(k) clearance (K902295) on December 11, 1990. It is classified as a Class II medical device under regulation number 872.3930 with product code LYC.

• Is Osteograf/N Natural Hydroxyapatite reusable?

  No, Osteograf/N Natural Hydroxyapatite is supplied as a single-use product. It is designed for one-time implantation in dental surgical procedures and should not be reused for patient safety reasons.