NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT

K063549 · Novabone Products, LLC · LYC · Feb 12, 2007 · Dental

Device Facts

• Record ID: K063549
• Device Name: NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT
• Applicant: Novabone Products, LLC
• Product Code: LYC · Dental
• Decision Date: Feb 12, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of NovaBone Dental Putty is to provide a safe, biocompatible synthetic bone graft material for use in oral, dental intraosseous, and craniofacial defects. It is used alone in a manner comparable to autogenous bone graft chips or allograft bone particulate (Demineralized Freeze Dried Bone) or may be mixed with either (typically 1:1 ratio v/v) as a bone graft extender. Typical uses include: - Periodontal/Infrabony defects - Ridge Augmentation (sinusotomy, osteotomy, cystectomy) - Extraction sites (ridge maintenance/augmentation, implant preparation/ placement) - Sinus lifts - Cystic cavities - Cranio-facial augmentation For larger defects, a mixture of NovaBone Dental Putty with an equal volume of allograft or autograft bone and bone marrow may improve new bone formation.

Device Story

NovaBone Dental Putty is an osteoconductive, bioactive bone void filler. It consists of calcium-phosphorus-sodium-silicate (45S5 Bioglass) particulate mixed with a synthetic binder. Supplied as a premixed, pliable, cohesive material. Used by clinicians in dental/craniofacial procedures to fill bony voids or gaps. Upon implantation, the binder is absorbed, allowing tissue infiltration between Bioglass particles. The bioactive glass acts as a scaffold for new bone growth, eventually being replaced by natural bone tissue. The device is non-structural and requires internal/external stabilization if load support is needed. Benefits include providing a synthetic alternative to autogenous or allograft bone grafts for bone regeneration.

Clinical Evidence

In vivo performance data and supporting in vitro data were provided to demonstrate substantial equivalence. No specific clinical trial metrics (e.g., sensitivity, specificity) are reported; the device relies on established biocompatibility and osteoconductive performance of the 45S5 Bioglass material used in predicate devices.

Technological Characteristics

Composition: Calcium-phosphorus-sodium-silicate (45S5 Bioglass) particulate and synthetic binder. Form: Premixed, pliable, cohesive putty. Principle: Osteoconductive, non-structural scaffold for bone regeneration. Sterilization: Supplied sterile. Connectivity: None (standalone).

Indications for Use

Indicated for patients requiring bone void filling or augmentation in oral, dental intraosseous, and craniofacial defects, including periodontal/infrabony defects, alveolar ridge augmentation, dental extraction sites, sinus lifts, and cystic defects. Contraindicated for load-bearing defects requiring mechanical support; not for use to gain screw purchase or stabilize screw placement.

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

• PerioGlas - Synthetic Bone Graft Particulate (K053387, K040278, K992416, K962492, K930115)
• NovaBone Putty II - Bioactive Synthetic Graft (K060728)
• Exactech Resorbable Bone Paste (K020078)
• Grafton DBM (K051195)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for NOVABONE synthetic bone graft products. The logo is black and white and features the word "NOVABONE" in large, bold letters. Below the word "NOVABONE" is the phrase "SYNTHETIC BONE GRAFT PRODUCTS" in smaller letters. Above the word "NOVABONE" is the text "K063549" in a stylized font.

FEB 12 2007
K-6.

11/21/06

ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ

2

ીને

# 510(k) Summary NovaBone Dental Putty - Bioactive Synthetic Bone Graft

#### 1. Submitter Information:

| Name: | NovaBone Products, LLC |
|------------|----------------------------------------------------|
| Address: | 13709 Progress Boulevard, #33<br>Alachua, FL 32615 |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| Contact: | David M. Gaisser |

#### 2. Name of Device:

| Trade Name: | NovaBone Dental Putty – Bioactive Synthetic Bone Graft |
|----------------------|------------------------------------------------------------------------------|
| Common Name: | Osteoconductive Bone Void Filler<br>Synthetic Resorbable Bone Graft Material |
| Classification Name: | Endosseous Implant for Bone Filling and/or Augmentation |

#### 3. Legally Marketed Predicate Device:

| Predicate #1: | PerioGlas - Synthetic Bone Graft Particulate<br>[K053387, K040278, K992416, K962492, K930115]<br>(Also named as NovaBone per Special 510(k) K000149) |
|---------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate #2: | NovaBone Putty II - Bioactive Synthetic Graft<br>[K060728] |
| Predicate #3: | Exactech Resorbable Bone Paste - [K020078] |
| Predicate #4: | Grafton DBM - [K051195] |

#### 4. Device Description

NovaBone Dental Putty is an osteoconductive, bioactive, bone void filler device. The device is intended for dental intraosseous, oral, and cranio-/maxillofacial bony defects and is supplied sterile. It is composed of a calcium-phosphorussodium-silicate (Bioglass) particulate mixed with a synthetic binder that acts as a temporary binding agent for the particulate. The particulate and binder are provided premixed as a pliable cohesive material. On implantation, the binder is absorbed to permit tissue infiltration between the Bioglass particles. The particles are slowly absorbed and replaced by new bone tissue during the healing process. The device is intended for dental intraosseous, oral, and cranio-/maxillofacial bony defects. It is supplied sterile.

#### 5. Intended Use

NovaBone Dental Putty is indicated to be packed into bony voids or gaps to fill and/or augment oral, dental intraosseous, and craniofacial defects. These defects

NOVABONE PRODUCTS, LLC

13709 PROGRESS BLVD., #33 • ALACHUA, FL 32615 • [phone] • FAX [phone]

www.novabone.com

{1}------------------------------------------------

Confidential
K063549

include: periodontal/infrabony defects; alveolar ridge may augmentation (sinusotomy, osteotomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation. NovaBone Dental Putty may be used alone in a manner comparable to autogenous bone graft chips or allograft bone particulate (demineralized freeze dried bone), or it may be mixed with either as a bone graft extender.

#### Technological Characteristics 6.

The technological characteristics of the NovaBone Dental Putty device are similar to those of the predicates. The device and the predicates are designed as osteoconductive space-filling devices to be gently packed into defect sites and used as non-structural scaffolds for the body's natural healing and bone regeneration process. The device indications are the same as for the PerioGlas predicate.

The NovaBone Dental Putty device is identical in composition and formulation to the NovaBone Putty II predicate device. The primary component of NovaBone Dental Putty is identical to the bioactive glass (45S5 Bioglass) particulate found in the PerioGlas and NovaBone Putty II predicates. This synthetic material is both biocompatible and osteoconductive. NovaBone Dental Putty also includes a synthetic binder as an inert carrier for ease of handling and delivery, forming a premixed cohesive material. The binder is biocompatible and is absorbed after implantation, opening space between the bioactive glass particles for cell infiltration and bone formation. The bioactive glass particulate remains for a longer post-implantation period, acting as a scaffold for bone ingrowth. This particulate is absorbed and replaced by new bone tissue.

#### 7. Warnings and Precautions

NovaBone Dental Putty does not possess sufficient mechanical strength to support load-bearing defects prior to hard tissue ingrowth. In cases where load support is required, standard internal or external stabilization techniques must be followed to obtain rigid stabilization in all planes.

NovaBone Dental Putty is intended for use by clinicians familiar with bone grafting and internal/external fixation techniques. NovaBone Dental Putty must not be used to gain screw purchase or to stabilize screw placement.

#### 8. Complications

Possible complications are the same as to be expected of autogenous bone grafting procedures. These may include: superficial wound infection, deep wound infection, deep wound infection with osteomyelitis, delayed union, loss of reduction, failure of fusion, loss of bone graft, graft protrusion and / or dislodgement, and general complications that may arise from anesthesia and / or surgery. Complications specific to oral/dental use are those as may be typically observed for similar bone grafting procedures and may include: tooth sensitivity,

{2}------------------------------------------------

510(k) Premarket Notification NovaBone Products, LLC NovaBone Putty II - Bioactive Synthetic Graft

Confidential

K063549

gingival recession, flap sloughing, resorption or ankylosis of the treated root, abscess formation.

#### 9. Conclusion

NovaBone Dental Putty is claimed to be substantially equivalent to the PerioGlas, NovaBone Putty, Exactech Resorbable Bone Paste, and Grafton DBM predicate devices as a non-structural osteoconductive bone void filler for osseous defects. In vivo performance data were presented. Additional supporting in vitro data were supplied.

{3}------------------------------------------------

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David M. Gaisser Vice President NovaBone Products, LLC One Progress Boulevard, Suite 33 Alachua, Florida 32615

EB 1 2 2007

Re: K063549

Trade/Device Name: NovaBone Dental Putty-Bioactive Synthetic Bone Graft Regulation Number: 872. 3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: November 21, 2006 Received: December 4, 2006

Dear Mr. Gaisser:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{4}------------------------------------------------

## Page 2 - Mr. Gaisser

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Guglia y. Michael MD.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Confidential

510(k) Premarket Notification NovaBone Products, LLC NovaBone Dental Putty - Bioactive Synthetic Bone Graft

K063549

STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known):

Device Name: NovaBone Dental Putty - Bioactive Synthetic Bone Graff

Indications For Use:

The intended use of NovaBone Dental Putty is to provide a safe, biocompatible synthetic bone graft material for use in oral, dental intraosseous, and craniofacial defects. It is used alone in a manner comparable to autogenous bone graft chips or allograft bone particulate (Demineralized Freeze Dried Bone) or may be mixed with either (typically 1:1 ratio v/v) as a bone graft extender. Typical uses include:

- · Periodontal/Infrabony defects
- · Ridge Augmentation (sinusotomy, osteotomy, cystectomy)
- · Extraction · sites (ridge maintenance/augmentation, implant preparation/ placement)
- Sinus lifts
- · Cystic cavities
- · Cranio-facial augmentation

For larger defects, a mixture of NovaBone Dental Putty with an equal volume of allograft or autograft bone and bone marrow may improve new bone formation.

Prescription Use __XX_

OR (Per 21 CFR 801.109) Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Supa Runos

- (Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital. Infection Control, Dental Devices
510(k) Number: K96354