OSTEOGRAF/N-300 HYDROXYLAPATITE

K960348 · Ceramed Corp. · LYC · Apr 22, 1996 · Dental

Device Facts

• Record ID: K960348
• Device Name: OSTEOGRAF/N-300 HYDROXYLAPATITE
• Applicant: Ceramed Corp.
• Product Code: LYC · Dental
• Decision Date: Apr 22, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of OsteoGraf/N-300 is for the filling of periodontal defects and augmentation of bony defects of the alveolar ridge, including tooth extraction sites.

Device Story

OsteoGraf/N-300 is a natural, high-purity, radiopaque, polycrystalline hydroxylapatite bone graft material; derived from bovine bone; processed into anorganic, rounded, irregular particles sized 250-420 microns. Used by clinicians for filling periodontal defects and augmenting alveolar ridge bony defects, including tooth extraction sites. Provides scaffold for bone growth; radiopacity allows visualization via X-ray. No electronic or software components.

Clinical Evidence

No clinical data provided; substantial equivalence based on chemical composition and material characterization.

Technological Characteristics

Material: 100% anorganic hydroxylapatite (Ca10(PO4)6OH2). Particle size: 250-420 microns. Conforms to ASTM F1581. Radiopaque. Polycrystalline structure.

Indications for Use

Indicated for patients requiring filling of periodontal defects or augmentation of alveolar ridge bony defects, including post-tooth extraction sites.

Regulatory Classification

Identification

Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

Special Controls

*Classification.* (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• OsteoGraf/D-700 (previously OsteoGraf/AR)

Submission Summary (Full Text)

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K960348
510(k) SUMMARY
K960348

January 22, 1996

APR 22 1996

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

1. **Submitter:**
CeraMed Corporation
12860 West Cedar Drive
Lakewood, CO 80228
[phone]

2. **Device Name:**
OsteoGraf/N-300 Hydroxylapatite
Classification Name: Endosseous implant for bone filling and/or augmentation

3. **Predicate Device:**
OsteoGraf/D-700 (previously OsteoGraf/AR) and others

4. **Device Description:**
OsteoGraf/N-300 is a natural, high purity, radiopaque, polycrystalline form of hydroxylapatite, the major mineral phase of bone and dental enamel. It is manufactured as anorganic, rounded, irregular shaped bovine derived hydroxylapatite particles, sized at 250-420 microns.

5. **Intended Use:**
The intended use of OsteoGraf/N-300 is for the filling of periodontal defects and augmentation of bony defects of the alveolar ridge, including tooth extraction sites.

6. **Comparison of Product Characteristics:**
OsteoGraf/N-300 consists of 100% anorganic hydroxylapatite, Ca₁₀(PO₄)₆OH₂.

X-ray diffraction and infrared analysis (FTIR) show OsteoGraf/N-300 to be 100% hydroxylapatite. OsteoGraf/N-300 conforms to the requirements of ASTM standard #F1581, "Composition of Anorganic Bone for Surgical Implants."