Calcitite Bone Graft Mat/Oral & Maxillofacial Surg

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

510(k) Number

K852682 ↗

FDA Product Code

LYC

Device Class

Class II

Regulation

21 CFR Part 872.3930

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• O-Ring Prosthetic Attachment Device

  Class II

  FDA 510(k) K900545 Active Cleared 22 Jun 1990

• Calcitek Torque Wrench System

  Class II

  FDA 510(k) K931440 Active Cleared 26 Jan 1994

• Integral III Biointegrated Dental Implant System

  Class II

  FDA 510(k) K925490 Active Cleared 1 Aug 1994

• Integral Plus Biointegrated Dental Implant System

  Class II

  FDA 510(k) K900549 Active Cleared 28 Jun 1990

• Bur, Dental (76EJL)

  Class II

  FDA 510(k) K915597 Active Cleared 5 Feb 1992

• Calcitek Ha-Coated Endosseous Dental Implant Systems

  Class II

  FDA 510(k) K960021 Active Cleared 8 Feb 1996

See all devices from Calcitek, Inc. →

• What types of surgical procedures is the Calcitite Bone Graft Mat intended for, and how does it support bone healing?

  The Calcitite Bone Graft Mat is specifically designed for oral and maxillofacial surgical applications, where it is used to fill, augment, or reconstruct bony defects in the periodontal or maxillofacial regions. It provides structural support during the bone healing process, helping to maintain space and stability while new bone tissue forms.

• Is the Calcitite Bone Graft Mat reusable, or is it intended for single-use only? How should it be handled to ensure sterility?

  The Calcitite Bone Graft Mat is supplied as a sterile, single-use material. To maintain sterility, it should remain unopened until immediately before use and handled with sterile instruments or gloves. After opening, it should be used promptly and discarded following a single application to avoid contamination.

• What regulatory pathway does the Calcitite Bone Graft Mat follow, and how is its compliance verified?

  The Calcitite Bone Graft Mat follows the FDA 510(k) clearance pathway, with the clearance number K852682. Its compliance is verified through multiple registration numbers and FEI numbers listed in the U.S. regulatory system, ensuring adherence to 21 CFR 872.3930 and other relevant guidelines. These identifiers help track distribution and confirm regulatory compliance.

• Are there different sizes or models of the Calcitite Bone Graft Mat available, and how would I determine the appropriate one for a procedure?

  While the provided data does not specify exact sizes or models, the Calcitite Bone Graft Mat is designed to accommodate various bony defects in oral and maxillofacial surgery. The manufacturer likely offers multiple dimensions to match clinical needs—consulting the product packaging, technical documentation, or Calcitek’s support team would help identify the correct size for a specific procedure.