Osteograf/p Periodontal Hydroxylapatite, 40-60

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

510(k) Number

K891173 ↗

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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  Class II

  FDA 510(k) K960361 Active Cleared 15 Apr 1996

• Osteograf Stainless Steel Syring

  Class II

  FDA 510(k) K962786 Active Cleared 1 Aug 1996

• Permaridge Syringe

  Class II

  FDA 510(k) K962838 Active Cleared 20 Aug 1996

• Osteograf/Ld-300 Hydroxylapatite

  Class II

  FDA 510(k) K942212 Active Cleared 23 Aug 1994

• Osteograf/N Natural Hydroxylapatite, 40-60 Mesh

  Class II

  FDA 510(k) K902295 Active Cleared 11 Dec 1990

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

  Class II

  FDA 510(k) K921469 Active Cleared 25 Jun 1992

See all devices from Ceramed Corp. →

• What is the intended use of Osteograf/p Periodontal Hydroxylapatite, 40-60?

  Osteograf/p Periodontal Hydroxylapatite, 40-60 is a synthetic bone grafting material used in dental applications, specifically for periodontal procedures where bone regeneration is needed to support teeth or prepare sites for implants.

• How is Osteograf/p Periodontal Hydroxylapatite, 40-60 supplied and packaged?

  The device is supplied as a synthetic hydroxyapatite particulate material in a sterile, single-use format, typically packaged in vials or syringes for direct application to the surgical site during periodontal grafting procedures.

• Is Osteograf/p Periodontal Hydroxylapatite, 40-60 sterile and intended for single use?

  Yes, the device is provided in a sterile condition and is designed for single-use only; it must not be resterilized or reused due to the risk of contamination, loss of integrity, or compromised biological performance.

• What regulatory pathway was used for Osteograf/p Periodontal Hydroxylapatite, 40-60, and what is its classification?

  Osteograf/p Periodontal Hydroxylapatite, 40-60 received FDA 510(k) clearance under K891173 on September 1, 1989, and is classified as a Class II medical device under regulation 872.3930 for synthetic bone grafting materials.

• What are the storage and handling requirements for Osteograf/p Periodontal Hydroxylapatite, 40-60?

  The device should be stored in a cool, dry place away from direct sunlight and extreme temperatures, as specified by the manufacturer, to maintain sterility and material integrity until the point of use.