PERIOGLAS- BIOGLASS BONE GRAFT PARTICULATE

K992416 · Usbiomaterials Corp. · LYC · Oct 15, 1999 · Dental

Device Facts

• Record ID: K992416
• Device Name: PERIOGLAS- BIOGLASS BONE GRAFT PARTICULATE
• Applicant: Usbiomaterials Corp.
• Product Code: LYC · Dental
• Decision Date: Oct 15, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K992416 · Oct 15, 1999	PERIOGLAS- BIOGLASS BONE GRAFT PARTICULATE	Usbiomaterials Corp.	Retrospective clinical study; Documented clinical case reports	Retrospective data from four clinicians and documented case reports were used to support the safety and efficacy of the device for ridge augmentation, extraction sites, sinus augmentation, and general osseous reconstruction.	Retrospective study; Case reports; Ridge augmentation; Sinus augmentation; Extraction sites

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Four clinician retrospective study; Retrospective study	Patients undergoing ridge augmentation, extraction sites, and sinus augmentation; Number of Sites: 4 clinicians	Not applicable for this study	Overall implant success rate

Indications for Use

PerioGlas® is intended to fill and/or augment dental intraosseous and oral/maxillofacial defects including: - Periodontal defects ● - Ridge augmentation . - Extraction Sites ● - Cranio-facial Augmentation . - Sinus Lifts . - Cystic Defects .

Device Story

PerioGlas® is a synthetic, osteoconductive bone void filler composed of Bioglass® (CaO, Na2O, SiO2, P2O5) in 90-710 um particulate form. Supplied sterile in a cup; mixed with saline or patient blood to create a sandy paste. Applied by clinicians to dental/oral/maxillofacial defects to facilitate bone repair. Acts as a scaffold for bone growth; can be used alone or as an extender for autogenous/allograft bone. Benefits include safe, biocompatible bone augmentation in various clinical scenarios (e.g., ridge, sinus, cystic defects).

Clinical Evidence

Clinical evidence includes prospective, retrospective, and case studies across various dental/oral/maxillofacial defects. Periodontal studies showed no significant differences between PerioGlas®/bone mixtures and PerioGlas® alone regarding Clinical Attachment Level (CAL), Pocket Depth Reduction (PDR), and osseous fill. A four-clinician retrospective study reported a 91% implant success rate for ridge augmentation, extraction sites, and sinus augmentation. Animal models (rabbit calvarial, canine split-rib) demonstrated superior bone formation when using PerioGlas® as a graft extender compared to either material alone.

Technological Characteristics

Synthetic osteoconductive particulate; composition: 24.5 wt% CaO, 24.5 wt% Na2O, 45 wt% SiO2, 6 wt% P2O5; particle size 90-710 um. Supplied sterile in Tyvek-sealed PET-G cup. Mechanical filler; no energy source or software.

Indications for Use

Indicated for patients requiring bone graft material for oral/maxillofacial and dental intraosseous defects, including periodontal/infrabony defects, ridge augmentation, extraction sites, cranio-facial augmentation, cystic cavities, and sinus lifts. Used alone or as a graft extender with autogenous bone or allograft bone particulate.

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

• Calcitite (K852682)
• Bio-Oss (K970321)

Submission Summary (Full Text)

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OCT 1 5 1999

Ka9q2416

# 510(k) Summary

#### General Information

| Classification Name: | Endosseous Implant for Bone Filling and/or Augmentation |
|----------------------|------------------------------------------------------------------------|
| Common Name: | Bioglass® Synthetic Bone Graft Particulate |
| Trade Name: | PerioGlas® |
| Submitter's Name : | USBiomaterials Corporation |
| Address: | One Progress Boulevard, #23<br>Alachua, FL 32615 |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| Contact: | Albert Fosmoe II, Director of Quality Assurance and Regulatory Affairs |
| Date of Summary: | July 1999 |

### Device Description

PerioGlas® is a synthetic osteoconductive particulate bone/void filler that is intended for oral/maxillofacial and dental intraosseous defects use. The material composed of Bioglass® (24.5 wt % CaO, 24.5 wt % Na20, 45 wt % SiO2, 6 wt % P2O5) with a particle size range of 90-710 um. It is supplied sterile in a Tyvek sealed PET-G cup that is protected by a shrink wrapped cardboard box. It is mixed with sterile water (saline) or the patient's own blood to form a wet sandy paste which is applied to the defect.

#### Predicate Device

PerioGlas® is substantially equivalent to legally marketed osteoconductive bone filling and/or augmentation devices in the U.S. including Calcitite (K852682) and Bio-Oss (K970321). Any minor differences between PerioGlas® and the predicate devices do not raise new questions of safety or effectiveness.

## Intended Use

PerioGlas® is intended to fill and/or augment dental intraosseous and oral/maxillofacial defects including:

- Periodontal defects ●
- Ridge augmentation .
- Extraction Sites ●
- Cranio-facial Augmentation .
- Sinus Lifts .
- Cystic Defects .

#### Device Testing

The performance of PerioGlas® was evaluated in animal models versus hydroxylapatite predicate devices. The rate of bone formation, amount of bone formed and the biomechanical

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properties including peak compressive loads and compressive stiffness were substantially equivalent to each other and normal bone.

PerioGlas® Bioglass® particulate was also evaluated as a graft extender with finely ground autogenous bone in a rabbit calvarial defect model and a canine split-rib model. In both of these models, bone formation or graft site augmentation was greater for the mixture of bone and Bioglass® than for either alone.

Clinical Data including prospective, retrospective and case studies were reviewed and evaluated for various dental and oral/maxillofacial intraosseous defects including a variety of ridge, periodontal, extraction sites, sinus augmentation and cystic defects using PerioGlas® alone and/or as a graft extender.

Periodontal studies showed no significant differences between PerioGlas®/Bone graft mixtures and PerioGlas® alone for a variety of clinical parameters including Clinical Attachment Level (CAL), Pocket Depth Reduction (PDR) and osseous fill. Results did suggest that there may be a synergistic effect when the two graft materials are combined.

Ridge augmentation, extraction site, sinus augmentation, cystic defect and general osseous reconstruction studies demonstrated safe and efficacious use of PerioGlas® alone and/or as a graft extender in these indications. Results from a four clinician retrospective study, as measured by the overall implant success rate (91%), indicate that the use of PerioGlas® as a bone graft extender is safe and efficacious for ridge augmentation, extraction sites and sinus augmentation.

Documented case reports representing all of the summarized categories with clinical evaluations and radiographs support the safety and efficacy of PerioGlas® alone or as a bone graft extender in bone/void filling.

#### Conclusions

The animal and/or clinical performance, safety and effectiveness data show that the device performs as well as or better than predicate hydroxylapatite devices as an osteoconductive bone void filler both alone or as a bone graft extender.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 5 1999

Mr. Albert Fosmoe II Director of Regulatory Affairs US Biomaterials Corporation One Progress Boulevard #23 Alachua, Florida 32615

K992416 Re : Perioglas - Bioglass Bone Graft Particulate Trade Name: Regulatory Class: Unclassified • Product Code: LYC Dated: July 16, 1999 Received: July 20, 1999

Dear Mr. Fosmoe II:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A . substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Paqe 2 - Mr. Fosmoe II

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Patrucco Cacciola Hoz

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| 510(k) Number (if known): | K992416 |
|---------------------------|------------|
| Device Name: | PerioGlas® |

Indications For Use:

The intended use of PerioGlas is to provide a safe, biocompatible synthetic bone graft material for oral/maxillofacial and dental intraosseous defects use. It is to be used alone in a manner comparable to autogenous bone graft chips or allograft bone particulate (DFDBA demineralized freeze dried bone) or may be mixed with each as a bone graft extender. Typical uses include:

- Periodontal/Infrabony defects .
- Ridge augmentation .
- Extraction sites .
- Cranio-facial augmentation .
- Cystic cavities .
- . Sinus lifts

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|------------------------------------------|----|----------------------|
|------------------------------------------|----|----------------------|

(Division Sign-Off)

Division of Dental, Infection Control,

and General Hospital Devices

| 510(k) Number | KC992416 |
|---------------|----------|
|---------------|----------|

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