(164 days)
Not Found
No
The device description and intended use clearly define it as a bone grafting material, with no mention of software, algorithms, or any AI/ML related terms. The performance studies focus on equivalence to predicate bone grafting materials.
Yes
The device is described as a bone grafting material intended to fill, augment, or reconstruct periodontal or bony defects, which are therapeutic actions addressing medical conditions.
No
The device is a bone grafting material intended to fill, augment, or reconstruct defects. It is a treatment device, not a diagnostic one.
No
The device description clearly states that MBCP+™ is a bone graft material consisting of a biphasic ceramic, available in different sizes of granules. This describes a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that MBCP+™ is a bone grafting material used to fill, augment, or reconstruct bony defects in the oral and maxillofacial region. This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The device is described as a synthetic biphasic ceramic material (hydroxyapatite and tricalcium phosphate beta) in granule form. This is consistent with a bone graft material, not a diagnostic test.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide information about a patient's health status or disease. IVDs are designed to perform tests on biological samples to aid in diagnosis, monitoring, or screening.
Therefore, MBCP+™ is a medical device used for surgical reconstruction, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
MBCP+™ is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or bony defects of the oral and maxillofacial region.
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 .
Product codes
LYC
Device Description
MBCP+™ is a bone graft material used in dental applications. The MBCP+™ product consists of a biphasic ceramic (e.g hydroxyapatite and tricalcium phosphate beta). MBCP+™ dental product is a synthetic device, available in different sizes of granules. MBCP+™ product is available sterile for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral and maxillofacial region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical performance data
Testing, performed according to the Guidance Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices; Guidance for Industry and FDA Staff issued April 28 2005, support the substantial equivalence between MBCP+ and the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
MAR 1 5 2010
Image /page/0/Picture/2 description: The image shows the word "Biomatlante" in a simple, sans-serif font. Above the word is a hexagonal shape filled with a dark, textured pattern, possibly representing a molecule or a cell structure. The overall design is clean and straightforward, suggesting a professional or scientific context for the brand or entity represented by the name.
Bone Grafting Material
Summary of Safety and effectiveness
A. Submitter's Name and adress
BIOMATLANTE ZA DES IV NATIONS 5, rue Edouard Belin -F- 44360 VIGNEUX DE BRETAGNE Phone: 0033 228 020 009 Fax: 0033 228 020 010
Jeanne CHAMOUSSET-ROMAN Contact: · Regulatory Affairs Manager
Summary preparation date: September 24th, 2009
B. Official Contact Person
RACQUEL Z LEGEROS, PHD
NEW YORK UNIV COLLEGE OF DENTISTRY 345 east 24th street rm 806 New York, NY 10010
Phone: 212 998 Fax: 212 995 Email: rzl1@nyu.edu
C. Establishment registration number : 3002673655
-
D. Device name
Bone Grafting Material -
E. Trade Name
MBCP+
Rev. 8ª February 2010
Section 04 Page 1 of 3
1
K093/22
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Bone Grafting Material
Summary of Safety and effectiveness
F. Device Classification Name
Bone Grafting Material (21 CFR 872.3930)
G. Proposed regulatory Class
Class II
H. Device Product Code
LYC
I. Panel Code
Dental
J. Legally marketed devices to which Biomatlante claims equivalence (Predicate devices)
| Product | Applicant | Class | 510(k) number |
|---|---|---|---|
| OsSatura™ Dental | Isotis Orthobiologics, Inc. | II | K042706 |
| Cerasorb™ Dental | Curasan AG | II | K051443 |
| MBCP™ | Biomatlante | II | K051885 |
K. Device Description
MBCP+™ is a bone graft material used in dental applications. The MBCP+™ product consists of a biphasic ceramic (e.g hydroxyapatite and tricalcium phosphate beta). MBCP+™ dental product is a synthetic device, available in different sizes of granules. MBCP+™ product is available sterile for single use.
Rev. 80 February 2010
Section 04 Page 2 of 3
2
K093/22
Image /page/2/Picture/1 description: The image shows the word "Biomatlante" in a simple, sans-serif font. Above the word is a hexagonal shape that appears to be a logo or symbol associated with the name. The hexagon has a textured or patterned fill, making it visually distinct from the text.
Bone Grafting Material
Summary of Safety and effectiveness
L. Intended use:
MBCP+™ is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or bony defects of the oral and maxillofacial region.
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 .
M. Summary of the technical characteristics
The bone substitutes concerns by this premarket notification and the predicate devices above mentioned have the same intended use, the same principle of operation and very similar technological characteristics. They are sterile devices made of calcium salt. MBCP+™ and predicates are provided sterile for single-use.
N. Non clinical performance data
Testing, performed according to the Guidance Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices; Guidance for Industry and FDA Staff issued April 28 2005, support the substantial equivalence between MBCP+ and the predicate device.
O. Conclusion
MBCP+™ is claimed to be substantially equivalent in term of safety and effectiveness to the predicate devices as a resorbable bone grafting material.
Rev. 8th February 2010
Section 04 Page 3 of 3
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 1 5 2010
Ms. Jeanne Chamousset-Roman Regulatory Affairs Manager Biomatlante 5 Rue Edouard Belin Za Les Quatre Nations Vigneux De Bretagne FRANCE 44360
Re: K093122
Trade/Device Name: MBCP+TM Regulation Number: 21CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: March 2, 2010 Received: March 4, 2010
Dear Ms. Roman:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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- Ms. Chamousset-Roman
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default .htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
for
Anthony D. Watson, B.S., M.S., M.B.A. 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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Bone Grafting Material
Indications for Use
510(k) Number (if known): _K093122
MBCP+™ Device Name:
Indications for Use:
MBCP+™ is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or bony defects of the oral and maxillofacial region.
These defects may be surgically created osseous defects or osseous defects created from traumatic injurv 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
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
W
Rev. 8th February 2010
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control. Dental Devices
Section 03 Page 1 of 1
510(k) Number: 4093122