(74 days)
Not Found
No
The summary describes a bone graft substitute material and its composition, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
Explanation: The device is a bone grafting material intended to fill, augment, or reconstruct bone defects, directly treating a physiological state (bone defects) to improve health or function.
No
The device is described as a "Resorbable Bone Graft Substitute" intended for filling, augmenting, or reconstructing bone defects. Its purpose is therapeutic (bone repair and regeneration), not diagnostic.
No
The device description clearly states it is a "Resorbable Bone Graft Substitute" composed of physical materials (Calcium Phosphate particles and an excipient) provided in a syringe, indicating it is a physical medical device, 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 Gel™ is a bone grafting material used to fill, augment, or reconstruct bone defects. This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The description details the composition and function of the material as a resorbable bone graft substitute that promotes bone ingrowth. This aligns with a medical device used for treatment or repair, not for analyzing samples to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. MBCP Gel™ does not fit this description.
N/A
Intended Use / 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 .
Product codes
LYC
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Osseous bone defects, periodontal or oral/maxillofacial applications.
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)
Not Found
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.
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Image /page/0/Picture/1 description: The image shows the logo for "Biomatlante". The logo consists of a stylized hexagon shape in black, with a jagged, uneven edge at the top, resembling a natural or organic form. Below the shape, the word "Biomatlante" is written in a simple, sans-serif font, with thin lines giving it a clean and modern appearance.
Image /page/0/Picture/2 description: The image shows a handwritten string of characters, "K060732". The characters are written in a dark ink on a white background. The handwriting is somewhat stylized, with the numbers having a rounded appearance.
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 : +33 228 02 00 09 | |
| myriamvincent@biomatlante.com | |
| 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
1
Image /page/1/Picture/0 description: The image shows the logo for Biomatiante. The logo consists of a black hexagon shape in the upper left corner, with the word "Biomatiante" written in a thin, sans-serif font below it. The text is slightly faded, giving it a subtle, textured appearance.
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
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the snake and staff. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus.
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.
3
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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
4
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, | |
| Section Control, Dental Devices | Page 1 of |
| 510(k) Number: | K060732 |