MBCP GEL

K060732 · Biomatlante · LYC · Jun 2, 2006 · Dental

Device Facts

• Record ID: K060732
• Device Name: MBCP GEL
• Applicant: Biomatlante
• Product Code: LYC · Dental
• Decision Date: Jun 2, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MBCP Gel™ is intended for use as a bone grafting material to fill, augment or reconstruct osseous bone defects in particular in periodontal or oral/maxillofacial applications. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MBCP Gel™ can generally be used for bone filling in closed cavities. MBCP Gel™ can be used with autogenous bone grafting materials. Typical uses include but are not limited to: - Periodontal/Infrabony defects - Ridge augmentation - Extraction sites (implant preparation/placement) - Sinus lifts - Cystic cavities

Device Story

MBCP Gel™ is a synthetic, resorbable bone graft substitute provided in a pre-filled syringe for single-patient use. It consists of biphasic calcium phosphate particles (60% hydroxyapatite, 40% beta-tricalcium phosphate) suspended in a pharmaceutical-grade hydroxypropylmethylcellulose aqueous gel carrier. The gel acts as a binder and spacer for the particles, facilitating handling and placement into osseous defects. The device is applied by a clinician during oral/maxillofacial surgical procedures. Once implanted, the gel provides an environment for bone ingrowth; the material is gradually resorbed and replaced by newly formed bone. It is intended for use in periodontal defects, ridge augmentation, extraction sites, sinus lifts, and cystic cavities, either alone or mixed with autogenous bone.

Clinical Evidence

No clinical data provided; substantial equivalence is supported by design, material, and performance information.

Technological Characteristics

Synthetic bone graft material composed of 60% hydroxyapatite and 40% beta-tricalcium phosphate particles in a hydroxypropylmethylcellulose aqueous gel carrier. Sterile, single-patient use, syringe-delivered. Resorbable, non-self-setting.

Indications for Use

Indicated for patients requiring bone grafting to fill, augment, or reconstruct osseous defects in periodontal or oral/maxillofacial applications, including surgically created defects or those resulting from traumatic injury. Suitable for use in closed cavities and in conjunction with autogenous bone grafting materials.

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

• MBCP™ (K051885)

Submission Summary (Full Text)

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JUN - 2 2006

-Confidential-

MBCP Gel™

# 510(k) Summary of Safety and Effectiveness

This 510(k) Summary for MBCP™ is provided as required per Section 513(1)(3) of the Food, Drug
and Cosmetic Act and Cosmetic Act.

## 1. GENERAL INFORMATION

| Submitter's name and adress : | BIOMATLANTE |
|-------------------------------|-----------------------------------|
| | ZA DES IV NATIONS |
| | 5, rue Edouard Belin |
| | -F- 44360 VIGNEUX DE BRETAGNE |
| | France |
| Contact : | Myriam VINCENT, |
| | Regulatory Affairs Manager |
| | Tel : [phone] |
| | [e-mail] |
| FDA Establishment Number : | 3002673655 |
| Trade Name: | MBCP Gel™ |
| Common Name: | Dental Bone Graft |
| Classification Name : | Bone Grafting Material, Synthetic |
| Product Code : | LYC |
| CFR Section : | 872.3930 |
| Device Panel : | Dental |

Summary preparation date:

March 6", 2006.

## 2. PREDICATE DEVICES

The subject device is substantially equivalent to similar previously cleared devices.

## 3. DEVICE DESCRIPTION

MBCP Gel™ is a Resorbable Bone Graft Substitute that is rapidly replaced by newly-formed bone. This material is a non self setting gel providing mechanical resistance after healing and osseous rehabilitation.

MBCP Gel™ is composed of biphasic Calcium Phosphate (60% Hydroxyapatite (HA) and 40% beta-Tricalcium Phosphate (β-ΤCP)) particles associated with an excipient with an excipient with an excipient with pharmaceutical grade (p TOP)) particles "associated" with "an" excipient" welicle of
pharmaceutical grade quality (hydroxypropylmethylcellulose in an aqueous solution). The s

Rev. 03/06/2006

Section 04 Page 1 of 2

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K060732
2072

-Confidential-

MBCP Gel™

## 510(k) Summary of Safety and Effectiveness

carrier acts as a spacer and a binder of the particles. MBCP Gel™ provides an environment for bone ingrowth. On time MBCP Gel™ is fully resorbable.

MBCP Gel™ is provided sterile for single patient use in a syringe.

#### 4. INTENDED USE

MBCP Gel™ is intended for use as a bone grafting material to fill, augment or reconstruct osseous bone defects in particular in periodontal or oral/maxill/facial (d) 1).
The marticular in periodontal or oral/maxill/facial applications.

These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

MBCP Gel™ can generally be used for bone filling in closed cavities.

MBCP Gel™ can be used with autogenous bone grafting materials.

Typical uses include but are not limited to:

- Periodontal/Infrabony defects .
- ◆ Ridge augmentation
- Extraction sites (implant preparation/placement) .
- Sinus lifts .
- . Cystic cavities

#### SUBSTANTIAL EQUIVALENCE INFORMATION 5.

The principal component and intended use of MBCP Gel™ is the same as previously cleared MBCP™ (K051885). MBCP Gel™ and the predicate devices are substantially equivalent in design, materials of construction and function.

The safety and effectiveness of MBCP Gel™ as a modification to MBCP™ presented in this submission is adequately supported by the substantial equivalence information, safety and performance data provided within this Premarket Notification.

Rev. 03/06/2006

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 2 2006

Ms. Myriam Vincent Regulatory Affairs Manager Biomatlantc ZA LES IV Nations 5. Rue Edouard Berlin F-44360 Vingneus de Bretagne FRANCE

Re: K060732

Trade/Device Name: MBCP GeI™ Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Synthetic Regulatory Class: II Product Code: LYC Dated: March 6, 2006 Received: March 20, 2006

Dear Ms. Vincent:

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.

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Page 2 - Ms. Vincent

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,

Shin-Jye, Ph.D.

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

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K060732

## Indications for Use

510(k) Number (if known):

Device Name: MBCP Gel™

## Indications For Use:

MBCP Gel™ is intended for use as a bone grafting material to fill, augment or reconstruct osseous bone defects in particular in periodontal or oral/maxillofacial applications.

These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

MBCP Gel™ can generally be used for bone filling in closed cavities.

MBCP Gel™ can be used with autogenous bone grafting materials.

Typical uses include but are not limited to:

- . Periodontal/Infrabony defects
- Ridge augmentation .
- Extraction sites (implant preparation/placement) .
- . Sinus lifts
- Cystic cavities .

Prescription Use " Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|----------------------------------------------------------------------------------|-----------|
| Division Sign-Off) | |
| Division of Anesthesiology, General Hospital,<br>Section Control, Dental Devices | Page 1 of |
| 510(k) Number: | K060732 |