(610 days)
Not Found
No
The device description focuses on the material properties and physical characteristics of a synthetic bone graft substitute. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are bench tests evaluating material properties, not algorithmic performance.
Yes
The device is described as a synthetic absorbable radiopaque silicated calcium-alkali-phosphate ceramic for filling, bridging and reconstructing bone defects and for bone fusion in dental and maxillofacial applications. Its intended use includes filling and/or reconstruction of bone defects, augmentation, and defect filling, all of which are therapeutic interventions aimed at restoring or improving physiological function.
No.
The device, Osseolive® DENTAL, is described as a synthetic absorbable radiopaque silicated calcium-alkali-phosphate ceramic intended for filling, bridging, and reconstructing bone defects and for bone fusion. Its intended use is therapeutic (repairing bone defects), not diagnostic (identifying or characterizing a disease or condition).
No
The device description clearly states that Osseolive® DENTAL is a synthetic absorbable radiopaque silicated calcium-alkali-phosphate ceramic, which is 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 describes the device as a material for filling, bridging, and reconstructing bone defects in oral and maxillofacial surgery and dentistry. This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The description details the material composition, structure, and how it functions within the body (resorption and substitution by bone). This aligns with a medical device used for treatment or repair, not for analyzing samples from the body to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (blood, tissue, etc.) or to provide information about a patient's health status or disease.
- Performance Studies: The performance studies described focus on material characteristics and degradation, which are relevant to the safety and efficacy of a bone graft substitute, not the performance of a diagnostic test.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Osseolive® DENTAL is indications in oral and maxillofacial surgery and dentistry, including filling and/or reconstruction of multi-walled (artificial or degenerative) bone defects, e.g .:
- Defects after the extirpation of bone cysts .
- Augmentation of an atrophied alveolar ridge ●
- Sinus lift or sinus floor elevation (subantral augmentation) ●
- Filing of alveolar defects after tooth extraction for preservation of the alveolar ridge
- Filling of extraction defects to create an implant bed .
- Filling of two- or multi-walled bone pockets as well as the bi- and trifurcation defects .
- . Defects after operative removal of retained teeth or corrective osteotomies
Product codes (comma separated list FDA assigned to the subject device)
LYC
Device Description
Osseolive® DENTAL is a synthetic absorbable radiopaque silicated calcium-alkali-phosphate ceramic for filling, bridging and reconstructing bone defects and for bone fusion in dental and maxillofacial applications.
Osseolive® DENTAL has an open-cellular porosity of about 80% and is available as polygonal granyles of various grain sizes. It is resorbed by the body over a period of months and simultaneously substituted by local autologous bone. As a synthetic, bioactive ceramic material Osseolive® DENTAL has excellent intra- and extra-osseous tissue compatibility and is neither locally nor systemically toxic.
Osseolive® DENTAL is a calcium-sodium phosphate with an open sintered structure. Osseolive® DENTAL morsels are highly porous, available in different grain size fractions between 150 and 2000 um. The high porosity allows blood components and body fluids to penetrate the material rapidly and unhindered.
The chemical composition is a modification of tricalcium phosphate, where one calcium atom is replaced by one potassium atom and one sodium atom, resulting in increased solubility.
Doping this glass ceramic with 4% sodium-magnesium-silicate on interstitial positions ensures the maximum mechanical stability.
Osseolive® DENTAL has a resorption time of 3 to 12 months.
Osseolive® DENTAL morsels are packaged for sale in glass vials.
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)
Bench test summary:
Comparative testing of the subject device and predicate devices was undertaken by a GLP compliant third party test laboratory. The following material characteristics were assessed for each device for comparison purposes:
- Analyses of inorganic elements .
- Determination of bulk density according to USP 34 and porosity .
- X-rav characterization .
- FTIR characterization ●
- Characterization of crystallinity ●
- Phase analyses ●
- Determination of the specific surfaces (B.E.T. method) according to ASTM C 1251 and ● ASTM D 4780
- Micro structure characterization according to ISO 6474 and ASTM E 112 .
- Determination of Ca/P ratio per mass test material .
- Identification and qualification of degradation products according to DIN EN ISO 10993-14 .
- Determination of the pH value according to USP 34
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Osseolive® DENTAL 510(k)
Appendix B
510(k) Summary in accordance with 21 CFR 807.92(c)
Device Name:
Osseolive® DENTAL
Abbreviated
15 April 2011
Curasan AG. Frankfurt Facility Ernst-Wiss-Strasse 18 65933 Frankfurt Germany
3004847139
Curasan AG Lindigstrasse 4 63801 Kleinostheim
3003771570
Mr Roger Gray
Piazza Albania 10 00153 Rome
Phone: +49 (0)60 27 40 900 0
VP Quality and Regulatory Donawa Lifescience Consulting
+49 (0)60 27 40 900 29
+39 06 578 2665
+30 06 574 3786
Dental Bone Grafting Material
Glass ceramic bone grafting material
Bone grafting material is a material such as hydroxyapatite,
Class II Special Controls Guidance Document: Dental Bone
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.
Germany
Fax:
Italy
Fax:
LYC
872.3930
Dental
Class II
Email:
Phone:
Type of 510{k} submission:
Date of Submission:
Manufacturer:
FDA Registration Number:
510(k) Owner:
FDA Registration Number:
510(k) Submitter and Contact:
FDA Classification Name: Common Name: FDA Panel: FDA Classification:
FDA Regulation Number:
FDA Product Code:
FDA Identification:
FDA Guidance Applied:
FDA Guidance Applied:
FDA Guidance Applied:
510(k) for Osseolive® DENTAL
Appendix B
Grafting Material Devices
DEC 2 0 2012
U CLT.
1111105
1
Image /page/1/Picture/1 description: The image shows the word "curasan" in bold, black letters. The font is sans-serif and the letters are closely spaced together. The word appears to be a logo or brand name.
Indications for Use:
Osseolive® DENTAL is indications in oral and maxillofacial surgery and dentistry, including filling and/or reconstruction of multi-walled (artificial or degenerative) bone defects, e.g .:
- Defects after the extirpation of bone cysts .
- Augmentation of an atrophied alveolar ridge ●
- Sinus lift or sinus floor elevation (subantral augmentation) ●
- Filing of alveolar defects after tooth extraction for preservation of the alveolar ridge �
- Filling of extraction defects to create an implant bed .
- Filling of two- or multi-walled bone pockets as well as the bi- and trifurcation defects .
- . Defects after operative removal of retained teeth or corrective osteotomies
Technological and Performance Characteristics:
Osseolive® DENTAL is a synthetic absorbable radiopaque silicated calcium-alkali-phosphate ceramic for filling, bridging and reconstructing bone defects and for bone fusion in dental and maxillofacial applications.
Description
Osseolive® DENTAL has an open-cellular porosity of about 80% and is available as polygonal granyles of various grain sizes. It is resorbed by the body over a period of months and simultaneously substituted by local autologous bone. As a synthetic, bioactive ceramic material Osseolive® DENTAL has excellent intra- and extra-osseous tissue compatibility and is neither locally nor systemically toxic.
Osseolive® DENTAL is a calcium-sodium phosphate with an open sintered structure. Osseolive® DENTAL morsels are highly porous, available in different grain size fractions between 150 and 2000 um. The high porosity allows blood components and body fluids to penetrate the material rapidly and unhindered.
The chemical composition is a modification of tricalcium phosphate, where one calcium atom is replaced by one potassium atom and one sodium atom, resulting in increased solubility.
Doping this glass ceramic with 4% sodium-magnesium-silicate on interstitial positions ensures the maximum mechanical stability.
Osseolive® DENTAL has a resorption time of 3 to 12 months.
Osseolive® DENTAL morsels are packaged for sale in glass vials.
Predicate Device Comparison:
The predicate devices selected for comparison with Osseolive® DENTAL are identified as follows:
| Device: | PerioGlas |
|---|---|
| 510(k) Sponsor: | NovaBone Products, LLC |
| 510(k) Number: | K053387 |
| Clearance Date: | 14 February 2006 |
| FDA Product Code: | LYC |
| Classification Name: | Bone grafting material, synthetic |
| Regulation No: | 872.3930 |
| Device: | Ceracell® DENTAL |
|---|---|
| 510(k) Sponsor: | Curasan AG |
| 510(k) Number: | K103709 |
| Clearance Date: | 10 March 2011 |
| FDA Product Code: | LYC |
| Classification Name: | Bone grafting material, syntheti |
2
Image /page/2/Picture/1 description: The image shows the word "curasan" in a bold, sans-serif font. The letters are all lowercase and are closely spaced together. The word appears to be printed in black ink on a white background, creating a high contrast image.
Regulation No: ...............................................................................................................................................................
| Device: | Cerasorb® M DENTAL |
|---|---|
| 510(k) Sponsor: | Curasan AG |
| 510(k) Number: | K051443 |
| Clearance Date: | 22 July 2005 |
| FDA Product Code: | LYC |
| Classification Name: | Bone grafting material, synthetic |
| Regulation No: | 872.3930 |
Bench test summary:
Comparative testing of the subject device and predicate devices was undertaken by a GLP compliant third party test laboratory. The following material characteristics were assessed for each device for comparison purposes:
- Analyses of inorganic elements .
- Determination of bulk density according to USP 34 and porosity .
- X-rav characterization .
- FTIR characterization ●
- Characterization of crystallinity ●
- Phase analyses ●
- Determination of the specific surfaces (B.E.T. method) according to ASTM C 1251 and ● ASTM D 4780
- Micro structure characterization according to ISO 6474 and ASTM E 112 .
- Determination of Ca/P ratio per mass test material .
- Identification and qualification of degradation products according to DIN EN ISO 10993-14 .
- Determination of the pH value according to USP 34 �
Comparison summary:
The majority of the device characteristics for Osseolive® DENTAL are similar to one or more of the predicate devices. Where they are not similar, the differences have no significant effect on device safety or effectiveness.
Conclusion:
Based on the information contained within this submission, it is concluded that the Osseolive® DENTAL is substantially equivalent to the identified predicate devices already in interstate commerce within the USA.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines below it, representing the American people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 20, 2012
Curasan AG C/O Mr. Roger Gray Vice President Quality and Regulatory Donawa Lifescience Consulting SRL Piazze Albania 10 Rome, Italy 00153
Re: K111105
Trade/Device Name: Curasan Osseolive® DENTAL Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: December 14, 2012 Received: December 17, 2012
Dear Mr. Gray:
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 - Mr. Gray
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.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/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,
Anthong Lo minta
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Appendix A
Indications for Use Statement
510(k) Number (if known): K111105
Device Name: Curasan Osseolive® DENTAL
Indications for Use: Osseolive® DENTAL is indicated for applications in oral and maxillofacial surgery and dentistry, including filling and/or reconstruction of multiwalled thereful ourgery and dentisury, including filling a
walled (artificial or degenerative) bone defects, e.g.:
- Defects after the extirpation of bone cysts .
- Augmentation of an atrophied alveolar ridge ●
- Sinus lift or sinus floor elevation (subantral augmentation) .
- Filling of also are of ordtion (Subantral augmentation)
Filling of alveolar defects after tooth extraction for preservation of the alveolar
ridge . - Filling of extraction defects to create an implant bed ● ●
- Filing of two- now don'to create an implant bed
Filing of two- or multi-walled bone pockets as well as the bi- and trifurcation
defects - Defects after operative removal of retained teeth or corrective osteotomies
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 IS NOT WRITE PAGE IF NEEDED) PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Susan Runner DDS, MA |
|---|
| 2012.12.20 |
| 06:52:57 -05'00' |
(Division Sign-Off) (Division of Anestheslology, General Hospital Infection Control, Dental Devices
Kili 510(k) Number:_