(66 days)
MBCP™ is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects.
These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
MBCP™ can be used with autogenous bone grafting materials.
Typical uses include:
- Periodontal/Infrabony defects .
- Ridge augmentation .
- Extraction sites (implant preparation/placement) .
- Sinus lifts .
- Cystic cavities .
MBCP™ is a Resorbable Bone Graft Substitute.
MBCP™ is a microporous and macroporous biphasic calcium phosphate ceramic consisting of Hydroxyapatite (HA) and beta-Tricalcium Phosphate (ß-TCP).
MBCP™ presents a multidirectional interconnected porosity structure, similar to that of human cancellous bone.
MBCP™ is presented in a porous form required for the biological exchanges particularly for bone ingrowth and mineralization.
The balance of a stable component (HA) and a more bioactive component (B-TCP) allied to the porosity involves the controlled process of ceramic resorption and bone substitution.
When packed into the bony site, MBCP™ gradually resobs and is replaced with bone during the healing process.
This document is a 510(k) Summary of Safety and Effectiveness for the MBCPTM device, a resorbable calcium salt bone void filler. It describes the device, its intended use, and its substantial equivalence to previously cleared devices. However, the provided text does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.
The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive de novo performance studies with pre-defined acceptance criteria for every new submission. In this case, the document states: "The safety and effectiveness of MBCP™ Resorbable Bone Graft Substitute for Dental Bone Grafting is adequately supported by the substantial equivalence information as well as biocompatibility testing, safety and performance data provided within this Premarket Notification." This implies that the 'study' referred to is likely a combination of literature review, in vitro tests (biocompatibility), and possibly a verification of physical/chemical properties that align with the predicate device, rather than a clinical trial with specific performance metrics and acceptance thresholds.
Given the information provided, I cannot populate the table or answer the questions related to specific acceptance criteria, study design, sample sizes, expert involvement, or comparative effectiveness studies. The document emphasizes substantial equivalence based on material composition and intended use.
{0}------------------------------------------------
SEP 1 6 2005
Image /page/0/Picture/1 description: The image shows the logo for "Biomatlante". The logo consists of a hexagon shape in the upper left corner, with the word "Biomatlante" written in a simple, sans-serif font below the hexagon. The hexagon is shaded with darker colors on the top and left sides, creating a sense of depth.
МВСР™
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.
1. GENERAL INFORMATION
| Submitter's name and adress : | BIOMATLANTEZA DES IV NATIONS5, rue Edouard Belin-F- 44360 VIGNEUX DE BRETAGNEFrance |
|---|---|
| Contact : | Myriam VINCENT,Regulatory Affairs ManagerTel : +33 228 02 00 09myriamvincent@biomatlante.com |
| FDA Establishment Number : | 3002673655 |
| Trade Name: | MBCPTM |
| Common Name: | Resorbable Calcium Salt Bone Void Filler |
| Classification Name : | Dental Bone Grafting Material Device |
| Product Code : | LYC |
| CFR Section : | 21CFR part 872 |
| Device Panel : | Oral/Dental |
Summary preparation date:
September 12, 2005
2. PREDICATE DEVICES
The subject device is substantially equivalent to previously cleared devices.
3. DEVICE DESCRIPTION
MBCP™ is a Resorbable Bone Graft Substitute.
MBCP™ is a microporous and macroporous biphasic calcium phosphate ceramic consisting of Hydroxyapatite (HA) and beta-Tricalcium Phosphate (ß-TCP).
MBCP™ presents a multidirectional interconnected porosity structure, similar to that of human cancellous bone.
Rev. 09/12/2005
Section 04 Page 1 of 2
-Confidential-
{1}------------------------------------------------
-Confidential-
Image /page/1/Picture/2 description: The image shows the logo for "Biomatlante". The logo consists of a black hexagon shape in the upper left corner, with the word "Biomatlante" written in a stylized font below it. The font is thin and rounded, giving the logo a modern and clean look. The hexagon is solid black, providing a strong contrast to the white background.
МВСРТМ
510(k) Summary of Safety and Effectiveness
MBCP™ is presented in a porous form required for the biological exchanges particularly for bone ingrowth and mineralization.
The balance of a stable component (HA) and a more bioactive component (B-TCP) allied to the porosity involves the controlled process of ceramic resorption and bone substitution.
When packed into the bony site, MBCP™ gradually resorbs and is replaced with bone during the healing process.
4. INTENDED USE
MBCP™ is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects.
These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
MBCP™ can be used with autogenous bone grafting materials.
Typical uses include:
- Periodontal/Infrabony defects .
- ♥ Ridge augmentation
- Extraction sites (implant preparation/placement) .
- Sinus lifts .
- Cystic cavities .
5. SUBSTANTIAL EQUIVALENCE INFORMATION
The material composition of MBCP™ Resorbable Bone Graft Substitute for Dental Bone Grafting is the same as previously cleared MBCP™ (K032268, K043005). Intended Use of MBCP™ Bone Graft Substitute is substantially equivalent to the predicates.
The safety and effectiveness of MBCP™ Resorbable Bone Graft Substitute for Dental Bone Grafting is adequately supported by the substantial equivalence information as well as biocompatibility testing, safety and performance data provided within this Premarket Notification.
{2}------------------------------------------------
Image /page/2/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 on the right, which is a staff with two snakes coiled around it. To the left of the caduceus is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged in a circular fashion.
SEP 1 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Myriam Vincent Regulatory Affairs Manager Biomatlante ZA LES IV Nations 5, Rue Edouard Berlin F-44360 Vingneus de Bretagne FRANCE
Re: K051885
Trade/Device Name: MBCP Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: July 4, 2005 Received: July 12, 2005
Dear Ms. Vincent:
We have reviewed your Section 510(k) premarket notification of intent to market the device indication We have reviewed your Section 910(x) premaince nearlied in equivalent (for the indications referenced above and nave decembred the arreed predicate devices marketed in interstate for use stated in the encrosule) to regarly manonsal provice Amendments, or to commerce prior to May 26, 1776, the encordance with the provisions of the Federal Food. Drug. devices that have been reciassified in accordance what approval application (PMA).
and Cosmetic Act (Act) that do not require approval arravisions of the Act. The and Cosmetic Act (Act) that to not require approval controls provisions of the Act. The Act. The You may, merelore, market the devree, seejoer to mements for annual registration, listing of
general controls provisions of the Act include requirements for annual registrati general controls provisions of the receiners requirement of the mobilibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (Scc above) this etting major regulations affecting your device can
may be subject to such additional controls. Existing major regulation EDA m may be subject to such additional controls. Existing may or 898. In addition, FDA may be found in the Code of Poderal Reg...
publish further announcements concerning your device in the Federal Register.
{3}------------------------------------------------
Page 2 - Ms. Vincent
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA 3 issumted on a states complies with other requirements of the Act
that FDA has made a determination that your device complies with other requireme that FDA has made a decommandon that your stered by other Federal agencies. You must or any Federal statutes and regulations and himited to: registration and listing (21 comply with an the Act 31equirements) needed on the practice requirements as set CFR Part 807); labeling (21 CFRT art 800); good if applicable, the electronic forth in the quality systems (QB) regainstill (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000 product radiation control provisions (Section your device as described in your Section 510(k) I his letter will anow you to begin maneting your marketing your device to a legally premarket notification. The PDA midning of basification 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 If you desire specific advice ior your acon 2011 5. Also, please note the regulation entitled, comact the Office of Complanse as (21 t ) = (21CFR Part 807.97). You may obtain " Misoranding by reference to premainer from the Act from the Division of Small other general information on your responsed.com at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chris Lee, 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
{4}------------------------------------------------
K05/885
Indications for Use
510(k) Number (if known):
Device Name: MBCP™
Indications for Use:
MBCP™ is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects.
These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
MBCP™ can be used with autogenous bone grafting materials.
Typical uses include:
- Periodontal/Infrabony defects .
- Ridge augmentation .
- Extraction sites (implant preparation/placement) .
- Sinus lifts .
- Cystic cavities .
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
ਮ Prescription Use _ Part 21 CFR 801 Subpart D) AND/OR
(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)
Susan Ruorer
(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental Device
510(k) Number: K-05
Page 1 of
§ 872.3930 Bone grafting material.
(a)
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.(b)
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.