(436 days)
Not Found
No
The description focuses on the material and physical properties of a resorbable membrane for guided tissue and bone regeneration, with no mention of AI or ML technology.
No.
The device is a resorbable barrier membrane used in dental applications for guided tissue and bone regeneration, indicated for various surgical procedures, but it does not treat or cure a disease or condition, which is characteristic of a therapeutic device.
No
The provided text explicitly states the device is a "barrier membrane for guided tissue and bone regeneration in dental applications," and its indications for use involve augmentation, reconstruction, and filling of bone defects. There is no mention of it being used to detect, diagnose, or monitor a disease or condition.
No
The device description clearly states it is a physical, resorbable membrane derived from porcine mesothelium, which is a hardware component.
Based on the provided information, the Mesothelium Dental Membrane is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Mesothelium Dental Membrane Function: The description clearly states that the Mesothelium Dental Membrane is a "barrier membrane for guided tissue and bone regeneration in dental applications." It is implanted into the body to aid in healing and regeneration.
- Intended Use: The intended uses listed are all related to surgical procedures and tissue/bone regeneration within the mouth, not laboratory testing of specimens.
Therefore, the Mesothelium Dental Membrane is a medical device used for surgical implantation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Mesothelium Dental Membrane is indicated for: simultaneous use of GBR-membrane and implants, augmentation around implants placed in immediate extraction sockets, augmentation around implants placed in delayed extraction sockets, localized ridge augmentation for later implantation, alveolar ridge reconstruction for prosthetic treatment, filling of bone defects after root resection, cystectomy, removal of retained teeth, guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.
Product codes
NPL
Device Description
Mesothelium Dental Membrane is a barrier membrane for guided tissue and bone regeneration in dental applications. It is a resorbable porcine-mesothelium-derived extracellular matrix available as a lyophilized sheet. Mesothelium Dental Membrane is available in a variety of shapes and sizes. Furthermore, the device can be easily trimmed or shaped to the appropriate size to fit the defect to be treated. The device is packaged sterile in a double-layer package.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 DSM, a global science-based company. The logo consists of a stylized circular graphic on the left, followed by the letters "DSM" in bold, sans-serif font. Below the letters, the tagline "BRIGHT SCIENCE. BRIGHTER LIVING." is printed in a smaller font size. The overall design is clean and modern, reflecting the company's focus on innovation and improving lives through science.
Mesothelium Dental Membrane
JUL 1 1 2013
510(k) Summary
DSM Biomedical Submitted by: 735 Pennsylvania Drive Exton, PA 19341 USA
Lori Burns, MS, RAC Contact Person: Manager Regulatory Affairs Ph: (484) 713-2186 Fax: (484) 713-2903
July 2, 2013 Date Prepared: K121310 510(K) #:
Device:
| 'Trade Name: | Mesothelium Dental Membrane |
|---|---|
| Common/Usual Name: | Resorbable Membrane for Guided Tissue and Bone Regeneration |
| Classification Name: | Barrier, Animal Source, Dental |
| Proposed Classification: | 21 CFR 872.3930, Class II, NPL |
Device Description:
Mesothelium Dental Membrane is a barrier membrane for guided tissue and bone regencration in dental applications. It is a resorbable porcine-mesothelium-derived extracellular matrix available as a lyophilized sheet. Mesothelium Dental Membrane is available in a variety of shapes and sizes. Furthermore, the device can be casily trimmed or shaped to the appropriate size to fit the defect to be treated. The device is packaged sterile in a double-layer package.
1
Intended Use:
Mesothelium Dental Membrane is indicated for:
- . simultaneous use of GBR-membrane and implants.
- augmentation around implants placed in immediate extraction sockets. .
- augmentation around implants placed in delayed extraction sockets. .
- . localized ridge augmentation for later implantation.
- alveolar ridge reconstruction for prosthetic treatment. .
- filling of bone defects after root resection, cystectomy, removal of retained teeth. .
- guided bone regeneration in dehiscence defects. .
- guided tissue regencration procedures in pcriodontal defects. .
Predicate Devices:
| Manufacturer | Device | 510(k) |
|---|---|---|
| Ed. Geistlich Soehne Ag Fuer | ||
| Chemische Industrie | K050446 | Bio-Gide® |
| RTI Biologics | K073097 | CopiOs™ Pericardium Membrane |
Technological Characteristics:
The intended use, product design, material, function and target population of Mesothelium Dental Membrancs are substantially equivalent to the FDA cleared and legally marketed predicate devices Bio-Gide (K050446) and CopiOs Pericardium Membrane (K073097).
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
…
2
| Medical Device Name | Mesothelium Dental
Membrane | Bio-Gide | CopiOs Pericardium
Membrane |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Origin | Porcine | Porcine | Bovine |
| Device Characteristics | Extracellular matrix | Extracellular Matrix | Extracellular Matrix |
| | Cell-occlusive | Cell-occlusive | Cell-occlusive |
| | Implantable | Implantable | Implantable |
| | Resorbable | Resorbable | Resorbable |
| Intended Use | Mesothelium Dental
Membrane is
indicated for
simultaneous use of
GBR-membrane and
implants;
augmentation around
implants placed in
immediate extractions
sockets, augmentation
around implants
placed in delayed
extraction sockets,
localized ridge
augmentation for later
implantation, alveolar
ridge reconstruction
for prosthetic
treatment, filling of
bone defects after root
resection, cystectomy
removal of retained
teeth, guided bone
regeneration in
dehiscence defects,
guided tissue
regeneration
procedures in
periodontal defects. | Bio-Gide is indicated
for simultaneous use
of GBR-membrane
and implants;
augmentation around
implants placed in
immediate extractions
sockets, augmentation
around implants
placed in delayed
extraction sockets,
localized ridge
augmentation for later
implantation, alveolar
ridge reconstruction
for prosthetic
treatment, filling of
bone defects after root
resection, cystectomy
removal of retained
teeth, guided bone
regeneration in
dehiscence defects,
guided tissue
regeneration
procedures in
periodontal defects. | CopiOs is intended
for use in oral surgical
procedures as a
resorbable material
for augmentation
around implants
placed in immediate
extraction sockets,
augmentation around
implants placed in
delayed extraction
sockets; localized
ridge augmentation
for later implantation;
alveolar ridge
reconstruction for
prosthetic treatment;
filling of bone defects
after root resection,
cystectomy, removal
of retained teeth;
guided bone
regeneration in
dehiscence defects
and guided tissue
regeneration
procedures in
periodontal defects. |
| Biocompatibility | Yes | Yes | Yes |
| Non pyrogenic | Yes | Yes | Yes |
| Resorbable | Yes | Yes | Yes |
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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 features three abstract human figures connected by flowing lines. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W(066-G609 Silver Spring, MD 20993-0002
July 11, 2013
DSM Biomedical C/O Ms. Lori Burns, MS. RAC Manager, Regulatory Affairs 735 Pennsylvania Drive EXTON PA 19341
Re: K121310
Trade/Device Name: Mesothelium Dental Membrane Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPL Dated: July 2, 2013 Received: July 5, 2013
Dear Ms. Burns:
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.
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Page 2 - Ms. Burns
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 CFF Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/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,
Mary S. Runner -S
Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): _K121310
Device Name: Mesothelium Dental Membrane
Indications for Use: Mesothelium Dental Membrane is indicated for: simultaneous use of GBRmembrane and implants, augmentation around implants placed in immediate extraction sockets, augmentation around implants placed in delayed extraction sockets, localized ridge augmentation for later implantation, alveolar ridge reconstruction for prosthetic treatment, filling of bone defects after root resection, cystectomy, removal of retained teeth, guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.
The device is intended for one time use.
Prescription Use X (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)
Mary S. Runner -S
Susan Run DDS, MA 2013.07.11
11:29:45-04'00'
Page __ of
(Division Sign-Off) (Division Sign-On)
Division of Anesthestology, General Hospital Unfection Control, Dental Devices
s10(k) Number: K121510
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