PERIOGLAS - BIOGLASS BONE GRAFT PARTICULATE

K962494 · Usbiomaterials Corp. · LYC · Sep 20, 1996 · Dental

Device Facts

• Record ID: K962494
• Device Name: PERIOGLAS - BIOGLASS BONE GRAFT PARTICULATE
• Applicant: Usbiomaterials Corp.
• Product Code: LYC · Dental
• Decision Date: Sep 20, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Perioglas®-Bioglass® Bone Graft Particulate is indicated for use in infraboney pockets caused by periodontal disease, extraction sites, and ridge augmentation.

Device Story

Bioactive glass particulate (90-710 microns); synthetic bone grafting material. Implanted by clinicians in dental/periodontal surgical settings. Functions as osteoconductive scaffold; integrates into bone tissue; promotes new trabecular bone growth. Used for alveolar bone collapse prevention and ridge augmentation. Output is physical bone graft integration; assessed via radiographic analysis and palpation. Benefits include solid bone restoration and effective osseous grafting.

Clinical Evidence

Human clinical study in extraction sites (n=16 patients, 20 sites). Primary endpoints: bone growth and integration. Results: significant new trabecular bone growth at 2 months; radiographic integration confirmed at 8 weeks; solid bone by palpation; radiographic differences between glass and bone nearly disappeared at 6 months. 2-year follow-up confirmed effective osseous grafting and prevention of alveolar bone collapse. No adverse complaints reported.

Technological Characteristics

Bioactive glass particulate; particle size 90-710 microns. Synthetic bone graft material. No energy source or software components.

Indications for Use

Indicated for patients requiring bone filling or augmentation in infraboney pockets caused by periodontal disease, extraction sites, and alveolar ridge reconstruction/augmentation.

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

• Hapset (K930115)
• Osteogen (K930115)
• Periograf (K930115)
• Orthovita-Biogran (K952922)
• Orthovita-Biogran (K941780)

Submission Summary (Full Text)

{0}

USBiomaterials
K962494
SEP 20 1996

Section X- 510(k) Summary

# 510(k) Summary Statement (as required by section 807.92(c) Perioglas®-Bioglass® Bone Graft Particulate

Trade Name : Perioglas®- Bioglass® Bone Graft Particulate
Common Name : Synthetic Bone Grafting Material
Classification Name and No.: Bone Implant, Endosseous for Bone Filling and/or Augmentation 76LYC
Device Classification : Class III
Federal Register, Vol. 52, No. 155, Wednesday August 12, 1987, Section 872.3640, Docket Number 78N-2887.

Perioglas®-Bioglass® Bone Graft Particulate is a bioactive glass particulate (90-710 microns). Perioglas® has previously been shown to be substantially equivalent to a number of hydroxyapatite materials currently marketed, including Hapset™, Osteogen®, and Periograf® synthetic bone grafting materials. This equivalency was determined in Premarket Notification [510(k)] Number K930115, November 1993, in which Perioglas® is indicated for use in infraboney pockets caused by periodontal disease.

The intended uses have been extended to extraction sites and ridge augmentation based upon additional clinical data and determination of substantial equivalence to the legally marketed device Orthovita- Biogran™ (Ref. [510(k)]# K952922, K941780).

To confirm safety and efficacy, a recently completed human clinical study in extraction sites demonstrated favorable results for Perioglas® which documented significant new trabecular bone growth at two months after implantation. In this clinical study 16 patients and 20 sites were treated. At eight (8) weeks, radiographic analysis indicated that the Perioglas® integrated well into the bone tissue and by palpitation of the surgical sites, bone was pronounced solid. At six (6) months radiographic differences between the glass particles and bone tissue had nearly disappeared. Healing was uneventful without complaints from subjects. Two years follow-up demonstrated that Perioglas® is an effective osseous grafting material for the prevention of alveolar bone collapse restoration in extraction sites.

Physicians conclude that Perioglas® is both safe and effective in extraction sites and in reconstruction and augmentation of the alveolar ridge. Positive long-term results are expected, consistent with those documented for many years in the refereed literature in medicine and biomaterials.

Daphna Rachel Ariel / Submitter
Date: 6/22/96

USBiomaterials Corporation • One Progress Boulevard • #23 • Alachua, Florida 32615 • TEL [phone] • FAX [phone]