(148 days)
Not Found
No
The device description and intended use focus on the material properties and physical function of a bone mineral matrix and collagen, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for augmentation, reconstructive treatment, and filling of bony voids and gaps in maxillofacial surgery, implantology, and periodontology, which are therapeutic uses.
No
The device, Geistlich Bio-Oss, is a bone mineral matrix intended for filling and augmentation of bony voids and gaps in various dental and maxillofacial procedures. Its purpose is to facilitate bone regeneration and act as a scaffold, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly describes a physical bone mineral matrix and collagen material intended for surgical implantation, not a software product.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that Geistlich Bio-Oss® and Geistlich Bio-Oss Collagen® are materials intended for filling and augmenting bony voids and gaps within the body during surgical procedures. They are implanted materials, not devices used to analyze samples taken from the body.
- The intended uses are surgical procedures. The listed uses (augmentation, filling defects, elevation of sinus floor, etc.) are all surgical interventions performed directly on the patient.
- The device description focuses on the material properties and manufacturing process. The description details the composition (bovine bone mineral, collagen), structure (porous matrix), and sterilization method, all of which are relevant to an implantable device, not an IVD.
Therefore, based on the provided text, Geistlich Bio-Oss® and Geistlich Bio-Oss Collagen® are not IVDs. They are surgical bone graft materials.
N/A
Intended Use / Indications for Use
Geistlich Bio-Oss® is intended for the following uses:
- Augmentation or reconstructive treatment of the alveolar ridge;
- Filling of infrabony periodontal defects;
- Filling of defects after root resection, apicoectomy, and cystectomy;
- Filling of extraction sockets to enhance preservation of the alveolar ridge;
- Elevation of the maxillary sinus floor;
- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR); and
- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
Geistlich Bio-Oss Collagen® is intended for the following uses:
- Augmentation or reconstructive treatment of the alveolar ridge;
- Filling of periodontal defects;
- Filling of defects after root resection, apicoectomy, and cystectomy:
- Filling of extraction sockets to enhance preservation of the alveolar ridge:
- Elevation of the maxillary sinus floor;
- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR); and
- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
Product codes
NPM
Device Description
Geistlich Bio-Oss® spongiosa (cancellous) granules and Geistlich Bio-Oss® spongiosa (cancellous) Block (referred as Geistlich Bio-Oss®) are intended for filling and augmentation of bony voids and gaps in maxillofacial surgery, implantology, and periodontology according to the intended use of the product.
Geistlich Bio-Oss® is serving as a matrix consisting of interconnected macro- and micropores. The material is highly porous and has a large inner surface area.
Geistlich Bio-Oss® is a biocompatible bone mineral matrix and is manufactured from bovine bone in a validated multistage purification process to remove the organic components.
Due to the interconnected macro and microporous system the device is hydrophilic and easv to moisten.
Geistlich Bio-Oss® is packed in a double sterile barrier system consisting of a glass vial and an outer blister. Geistlich Bio-Oss is sterilized according to validated processes by y-irradiation. It is available in the following sizes and amounts:
Product Weight Particle Size
Geistlich Bio-Oss® spongiosa (cancellous) granules 0.25 g 0.25 - 1.0 mm
Geistlich Bio-Oss® spongiosa (cancellous) granules 0.5 g 0.25 - 1.0 mm
Geistlich Bio-Oss® spongiosa (cancellous) granules 2.0 g 0.25 - 1.0 mm
Geistlich Bio-Oss® spongiosa (cancellous) granules 5.0 g 0.25 - 1.0 mm
Geistlich Bio-Oss® spongiosa (cancellous) granules 0.5 g 1.0 - 2.0 mm
Geistlich Bio-Oss® spongiosa (cancellous) granules 2.0 g 1.0 - 2.0 mm
Geistlich Bio-Oss® spongiosa (cancellous) block
1 x 1 x 2 cm (approx.)
Geistlich Bio-Oss Collagen® is a combination of purified spongiosa (cancellous) bone mineral granules (Geistlich Bio-Oss®) and 10% collagen fibers in a block form.
The collagen facilitates handling and application of Geistlich Bio-Oss Collagen® and acts to hold the Bio-Oss particles at the desired place. The consistency of this material readily allows to take the shape of the defect. The collagen component is resorbed after application.
Geistlich Bio-Oss Collagen® is intended for filling and augmentation of bony voids and gaps in maxillofacial surgery, implantology, and periodontology according to the intended use of the product.
Geistlich Bio-Oss Collagen® is serving as a matrix consisting of interconnected macroand micropores. The material is highly porous and has a large inner surface area.
Geistlich Bio-Oss Collagen®is a biocompatible bone mineral matrix and is manufactured from boyine bone and collagen from connective tissue of pigs certified for human consumption according to a controlled and validated multistage purification process. From the bovine bone all organic components are removed.
Due to the interconnected macro and microporous system the device is hydrophilic and easy to moisten.
Geistlich Bio-Oss Collagen® is packed in a double sterile barrier system consisting of an inner and an outer blister. Geistlich Bio-Oss® is sterilized according to validated processes by y-irradiation. It is available as part of two convenience kits and different sizes:
Single Products:
- 1 block 100 mg Geistlich Bio-Oss® spongiosa (cancellous) granules and 10% collagen .
- 1 block 250 mg Geistlich Bio-Oss® spongiosa (cancellous) granules and 10% collagen .
- 1block 500 mg Geistlich Bio-Oss® spongiosa (cancellous) granules and 10% collagen .
Convenience Kits: - Geistlich Combi-Kit Collagen® .
- 1 block 100 mg Geistlich Bio-Oss® spongiosa (cancellous) granules and 10% collagen, and 1 Geistlich Bio-Gide® membrane, 16 x 22 mm
- Geistlich Perio System Combi-Pack . 1 block 100 mg Geistlich Bio-Oss® spongiosa (cancellous) granules and 10% collagen, and 1 Geistlich Bio-Gide® Perio membrane, 16 x 22 mm
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Maxillofacial, alveolar ridge, infrabony periodontal defects, defects after root resection, apicoectomy, cystectomy, extraction sockets, maxillary sinus floor, peri-implant defects
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Maxillofacial surgery, implantology, periodontology
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 tests compared Geistlich Bio-Oss® from standard manufacturing lots with Geistlich Bio-Oss® manufactured with raw material from an alternative geographic source.
X-ray diffraction analysis: No differences were revealed, confirmed as crystalline hydroxyapatite with no detectable impurities.
Fourier Transform Infrared Spectroscopy: Data from regular manufacturing lots were equal to those from the alternative geographic source.
Mercury Intrusion Porosimetry: Porosity, specific pore surface area, bulk density, and bimodal pore size distribution were identical.
Conclusion: Results of the bench tests support that Geistlich Bio-Oss® is Substantially Equivalent to the identified predicate devices.
Bench tests compared Geistlich Bio-Oss® from standard manufacturing lots with Geistlich Bio-Oss manufactured with raw material from an alternative geographic source.
X-ray diffraction analysis: No differences were revealed, confirmed as crystalline hydroxyapatite with no detectable impurities.
Fourier Transform Infrared Spectroscopy: Data from regular manufacturing lots were equal to those from the alternative geographic source.
Mercury Intrusion Porosimetry: Porosity, specific pore surface area, bulk density, and bimodal pore size were identical.
Conclusion: Geistlich Bio-Oss Collagen® is Substantially Equivalent to the identified predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K112572, K033815, K970321, K952618, K092428, K974399
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
510(k) Summary
FEB 1 5 2013
GEISTLICH BIO-OSS®
SPONSOR
Geistlich Pharma AG Bahnhofstrasse 40 CH-6110 Wolhusen Switzerland
Contact Person:
E-mail: Phone: Fax: Date Prepared: Daniel Kracov, Arnold & Porter, LLP Counsel to Geistlich Pharma AG Daniel.Kracov@aporter.com 202-942-5120 202-942-5999 February 13, 2013
DEVICE NAME
| Proprietary Name: | Geistlich Bio-Oss® |
|---|---|
| Common/Usual Names: | Bone Grafting Material |
| Classification Name: | Bone grafting material, animal source (NPM) |
PREDICATE DEVICES
Geistlich Bio-Oss® and Geistlich Bio-Oss® Blocks (K112572, K033815, K970321, K952618)
DEVICE DESCRIPTION
Geistlich Bio-Oss® spongiosa (cancellous) granules and Geistlich Bio-Oss® spongiosa (cancellous) Block (referred as Geistlich Bio-Oss®) are intended for filling and augmentation of bony voids and gaps in maxillofacial surgery, implantology, and periodontology according to the intended use of the product.
Geistlich Bio-Oss® is serving as a matrix consisting of interconnected macro- and micropores. The material is highly porous and has a large inner surface area.
Geistlich Bio-Oss® is a biocompatible bone mineral matrix and is manufactured from bovine bone in a validated multistage purification process to remove the organic components.
Due to the interconnected macro and microporous system the device is hydrophilic and easv to moisten.
1
Geistlich Bio-Oss® is packed in a double sterile barrier system consisting of a glass vial and an outer blister. Geistlich Bio-Oss is sterilized according to validated processes by y-irradiation. It is available in the following sizes and amounts:
| Product | Weight | Particle Size |
|---|---|---|
| Geistlich Bio-Oss® spongiosa (cancellous) granules | 0.25 g | 0.25 - 1.0 mm |
| Geistlich Bio-Oss® spongiosa (cancellous) granules | 0.5 g | 0.25 - 1.0 mm |
| Geistlich Bio-Oss® spongiosa (cancellous) granules | 2.0 g | 0.25 - 1.0 mm |
| Geistlich Bio-Oss® spongiosa (cancellous) granules | 5.0 g | 0.25 - 1.0 mm |
| Geistlich Bio-Oss® spongiosa (cancellous) granules | 0.5 g | 1.0 - 2.0 mm |
| Geistlich Bio-Oss® spongiosa (cancellous) granules | 2.0 g | 1.0 - 2.0 mm |
Geistlich Bio-Oss® spongiosa (cancellous) block
1 x 1 x 2 cm (approx.)
INTENDED USE
Geistlich Bio-Oss® is intended for the following uses:
-
Augmentation or reconstructive treatment of the alveolar ridge;
-
Filling of infrabony periodontal defects;
-
Filling of defects after root resection, apicoectomy, and cystectomy;
-
Filling of extraction sockets to enhance preservation of the alveolar ridge;
-
Elevation of the maxillary sinus floor;
-
Filling of periodontal defects in conjunction with products intended for Guided
Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR); and
- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
Appearance: white granulate or white, porous block
Moisture: less than 5% (w./w.)
Calcium: 35%-40% (w.lw.)
Phosphorous: 13.5% - 18.5% (w./w.)
SUMMARY OF DATA TO SUPPORT SUBSTANTIAL EQUIVALENCE
Geistlich Bio-Oss® from standard manufacturing lots was compared with Geistlich Bio-Oss® manufactured with the raw material from the alternative geographic source by means of X-ray diffraction analysis, Fourier Transform Infrared Spectroscopy and Mercury Intrusion Porosimetry.
The X-ray spectra of Geistlich Bio-Oss® manufactured with bovine bone from the alternative geographic source did not reveal any differences and confirmed that Geistlich Bio-Oss® is crystalline hydroxyapatite with no detectable impurities.
2
Fourier Transform Infrared Spectroscopy data was generated to determine the molecule structure characteristics of Geistlich Bio-Oss®. The data from regular manufacturing lots were equal to Geistlich Bio-Oss® manufactured from bovine bone of the alternative geographic source.
Mercury Intrusion Porosimetry revealed that porosity, specific pore surface area, bulk density and bimodal pore size distribution demonstrates that the micro and macro pores of Geistlich Bio-Oss® from regular manufacturing lots are identical to Geistlich Bio-Oss® manufactured from bovine bone of the alternative geographic source.
CONCLUSION
Results of the bench tests support that Geistlich Bio-Oss® is Substantially Equivalent to the identified predicate devices.
3
510(k) Summary
GEISTLICH BIO-OSS COLLAGEN®
SPONSOR
Geistlich Pharma AG Bahnhofstrasse 40 CH-6110 Wolhusen Switzerland
| Contact Person: | Daniel Kracov, Arnold & Porter, LLP
Counsel to Geistlich Pharma AG |
|-----------------|-----------------------------------------------------------------------|
| E-mail: | Daniel.Kracov@aporter.com |
| Phone: | 202-942-5120 |
| Fax: | 202-942-5999 |
| Date Prepared: | February 13, 2013 |
DEVICE NAME
| Proprietary Name: | Geistlich Bio-Oss Collagen® |
|---|---|
| Common/Usual Names: | Bone Grafting Material Plus Collagen |
| Classification Name: | Bone grafting material, animal source (NPM) |
PREDICATE DEVICES
Geistlich Bio-Oss Collagen® (K112572, K092428, K033815, K974399)
DEVICE DESCRIPTION GBOC
Geistlich Bio-Oss Collagen® is a combination of purified spongiosa (cancellous) bone mineral granules (Geistlich Bio-Oss®) and 10% collagen fibers in a block form.
The collagen facilitates handling and application of Geistlich Bio-Oss Collagen® and acts to hold the Bio-Oss particles at the desired place. The consistency of this material readily allows to take the shape of the defect. The collagen component is resorbed after application.
Geistlich Bio-Oss Collagen® is intended for filling and augmentation of bony voids and gaps in maxillofacial surgery, implantology, and periodontology according to the intended use of the product.
Geistlich Bio-Oss Collagen® is serving as a matrix consisting of interconnected macroand micropores. The material is highly porous and has a large inner surface area.
60123676v1
4
Geistlich Bio-Oss Collagen®is a biocompatible bone mineral matrix and is manufactured from boyine bone and collagen from connective tissue of pigs certified for human consumption according to a controlled and validated multistage purification process. From the bovine bone all organic components are removed.
Due to the interconnected macro and microporous system the device is hydrophilic and easy to moisten.
Geistlich Bio-Oss Collagen® is packed in a double sterile barrier system consisting of an inner and an outer blister. Geistlich Bio-Oss® is sterilized according to validated processes by y-irradiation. It is available as part of two convenience kits and different sizes:
Single Products:
- 1 block 100 mg Geistlich Bio-Oss® spongiosa (cancellous) granules and 10% collagen .
- 1 block 250 mg Geistlich Bio-Oss® spongiosa (cancellous) granules and 10% collagen .
- 1block 500 mg Geistlich Bio-Oss® spongiosa (cancellous) granules and 10% collagen .
Convenience Kits:
- Geistlich Combi-Kit Collagen® .
- 1 block 100 mg Geistlich Bio-Oss® spongiosa (cancellous) granules and 10% collagen, and 1 Geistlich Bio-Gide® membrane, 16 x 22 mm
- Geistlich Perio System Combi-Pack . 1 block 100 mg Geistlich Bio-Oss® spongiosa (cancellous) granules and 10% collagen, and 1 Geistlich Bio-Gide® Perio membrane, 16 x 22 mm
INTENDED USE
Geistlich Bio-Oss Collagen® is intended for the following uses:
-
Augmentation or reconstructive treatment of the alveolar ridge;
-
Filling of periodontal defects;
-
Filling of defects after root resection, apicoectomy, and cystectomy:
-
Filling of extraction sockets to enhance preservation of the alveolar ridge:
-
Elevation of the maxillary sinus floor;
-
Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR); and
-
Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
Appearance: white sponge-like, hard pieces of customized size
60123676v1
5
Water: less than 8% (w./w.) Calcium: 38%-42% (w./w.) Phosphorous: 12.5% - 17.5% (w./w.)
SUMMARY OF DATA TO SUPPORT SUBSTANTIAL EQUIVALENCE
Geistlich Bio-Oss® from standard manufacturing lots was compared with Geistlich Bio-Oss manufactured with the raw material from the alternative geographic source by means of X-ray diffraction analysis, Fourier Transform Infrared Spectroscopy and Mercury Intrusion Porosimetry.
The X-ray spectra of Geistlich Bio-Oss® manufactured from bovine bone of the alternative geographic source did not reveal any differences and confirmed that Geistlich Bio-Oss® is crystalline hydroxyapatite with no detectable impurities.
Fourier Transform Infrared Spectroscopy data was generated to determine the crystal structure, crystal size and molecule structure characteristics of Geistlich Bio-Oss® The data from reqular manufacturing lots were equal to Geistlich Bio-Oss® manufactured from bovine bone of the alternative geographic source.
Mercury Intrusion Porosimetry revealed that porosity, specific pore surface area, bulk density and bimodal pore size of Geistlich Bio-Oss® from regular manufacturing lots are identical to Geistlich Bio-Oss® manufactured from bovine bone of the alternative geographic source.
CONCLUSION
Geistlich Bio-Oss Collagen® is Substantially Equivalent to the identified predicate devices.
6
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure with three curved lines representing wings or streams.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 15, 2013
Geistlich Pharma AG C/O Mr. Daniel A. Kracov Arnold & Porter, Limited Liability Partnership 555 Twelfth Street, North West WASHINGTON DC 20004-1206
Re: K122894
Trade/Device Name: Geistlich Bio-Oss® and Geistlich Bio-Oss Collagen® Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPM Dated: January 31, 2013 Received: February 1, 2013
Dear Mr. Kracov:
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.
7
Page 2 - Mr. Kracov
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/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,
Mary S. Runner
Susan Runner, DDS, MA 2013.02.21
13:27:34 -05'00'
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
8
Indications for Use
K122894 510(k) Number (if known): (not yet known)
Device Name: Geistlich Bio-Oss®
Indications For Use:
Geistlich Bio-Oss® is intended for the following uses:
-
Augmentation or reconstructive treatment of the alveolar ridge;
-
Filling of infrabony periodontal defects;
-
Filling of defects after root resection, apicoectomy, and cystectomy;
-
Filling of extraction sockets to enhance preservation of the alveolar ridge;
-
Elevation of the maxillary sinus floor;
-
Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR); and
-
Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
AND/OR Prescription Use × CFR 801 Subpart D) (21 CFR 801 Subpart C) Over-The-Counter Use_ (Part 21
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------# [2013:02.15
09:45:55 -05'00' ADDAIA
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(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital Division Control, Dental Devices
510(k) Number;