(242 days)
Not Found
No
The device description and intended use clearly indicate that this is a physical collagen membrane and bone mineral product for guided tissue and bone regeneration, with no mention of software, algorithms, or data processing that would involve AI/ML.
No.
The intended uses listed primarily focus on augmentation, reconstruction, and filling of defects related to dental and bone structures, which are restorative or regenerative in nature, rather than directly therapeutic in the sense of treating a disease or condition for cure or alleviation. While these procedures improve patient health and function, the device itself acts as a scaffold or barrier for natural biological processes.
No
The device is a collagen membrane intended for tissue regeneration and reconstruction, not for diagnosis. Its uses include augmentation, filling bone defects, and guiding tissue and bone regeneration.
No
The device description clearly indicates that the devices are physical collagen membranes and kits containing physical components (collagen membrane and bone mineral). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to surgical procedures for bone and tissue regeneration in dental and oral surgery. These procedures involve direct intervention on the patient's body.
- Device Description: The device is described as a collagen membrane and a combination of bone mineral granules and collagen fibers. These are materials intended to be implanted or placed within the body to facilitate healing and regeneration.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health status. They are used outside the body (in vitro).
The Geistlich Bio-Gide® products are clearly intended for use within the body during surgical procedures, not for testing specimens outside the body.
N/A
Intended Use / Indications for Use
Geistlich Bio-Gide® is intended for the following uses:
- 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.
Geistlich Bio-Gide® Compressed is indicated 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.
- guided tissue regeneration procedures in periodontal defects.
Geistlich Bio-Gide® Perio is intended for the following uses:
- 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.
Geistlich Bio-Gide® Shape is indicated 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; and
- guided bone regeneration in dehiscence defects.
Geistlich Combi-Kit Collagen:
Geistlich Bio-Gide® is intended for the following uses:
- 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.
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).
Geistlich Perio-System Combi-Pack:
Geistlich Bio-Gide® Perio is intended for the following uses:
- 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.
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 (comma separated list FDA assigned to the subject device)
NPL, NPM
Device Description
Geistlich Bio-Gide® is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking and is sterilized by gamma irradiation.
Geistlich Bio-Gide® Shape is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells into the membrane, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The Geistlich Bio-Gide® Shape membrane has a pre-shaped form with a maximum width and height of 14 mm x 24 mm, respectively.
Geistlich Bio-Gide® Compressed is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells into the membrane, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The Geistlich Bio-Gide® Compressed membrane is available in two different sizes, 13 x 25 mm and 20 x 30 mm.
Geistlich Bio-Gide® Perio is a pure collagen membrane with a bilayer structure and smoothed dense (cell-occlusive) surface. The modified surface makes the membrane somewhat stiffer in the dry state, and this facilitates cutting the membrane for periodontal applications. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. Pre-formed sterile templates are provided to simplify the cutting of the respective membrane shape. Four templates (uncoated Tyvek®) are packaged with Geistlich Bio-Gide® Perio to serve as an aid to assist the clinician in trimming the Geistlich Bio-Gide® Perio membrane to fit the defect and are in varying shapes to fit the clinical need (e.g., rectangular, interproximal). The templates are packaged as an accessory product with Geistlich Bio-Gide® Perio.
Geistlich Combi-Kit Collagen is a convenience kit containing one unit of Geistlich Bio-Oss Collagen® and one unit of Geistlich Bio-Gide®. The two devices are packaged in double blisters in one package and then sterilized by gamma irradiation. Geistlich Bio-Oss Collagen® is a combination of purified spongiosa (cancellous) natural bone mineral granules and 10% collagen fibers in a block form (100 mg) and is sterilized by gamma irradiation. Geistlich Bio-Gide® is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking and is sterilized by gamma irradiation. The size of the Geistlich Bio-Gide® bilayer membrane to be provided in the Geistlich Combi-Kit Collagen convenience kit is 16 mm x 22 mm.
Geistlich Perio-System Combi-Pack is a convenience kit containing one unit of Geistlich Bio-Oss Collagen® and one unit of Geistlich Bio-Gide® Perio. Geistlich Bio-Oss Collagen® (sold either as an individual unit or as one of the components of Geistlich Perio-System Combi-Pack) is a combination of purified spongiosa (cancellous) natural bone mineral granules and 10% collagen fibers in a block form (100 mg) and is sterilized by gamma irradiation. Geistlich Bio-Gide® Perio (sold either as an individual unit or as one of the components of Geistlich Perio-System Combi-Pack) is a pure collagen membrane with a bilayer structure and smoothed dense (cell-occlusive) surface. The modified surface makes the membrane somewhat stiffer in the dry state, and this facilitates cutting the membrane for periodontal applications. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the defect. The membrane is made of collagen without further cross-linking and is sterilized by gamma irradiation. The size of the Geistlich Bio-Gide® Perio bilayer membrane to be provided in the Geistlich Perio-System Combi-Pack convenience kit and as individual units is 16 mm x 22 mm. Preformed sterile templates are provided to simplify the cutting of the respective membrane shape. Four templates (uncoated Tyvek®) are packaged with Geistlich Bio-Gide® Perio to serve as an aid to assist the clinician in trimming the Geistlich Bio-Gide® Perio membrane to fit the defect, and are in varying shapes to fit the clinical need (e.g., rectangular, interproximal). The templates are packaged as an accessory product with Geistlich Bio-Gide® Perio.
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
Prescription Use
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 data was not deemed necessary to support the changes to the product labeling or extension to the product line.
Results from biocompatibility, sterilization, shelf-life, and bench and clinical performance studies from the applicant's own predicate devices (K192042) was leveraged in support of substantial equivalence. The following standards were utilized:
- ISO 10993-2018 ●
- ISO 11137-1:2006 ●
- ISO 11137-2:2013
- ISO 11137-3:2017
Data from fifteen (15) clinical studies involving 297 unique patients covering conditions from dehiscence type defects at dental implant sites to extraction sockets with and without bone resorption support that complete wound closure is not required for Geistlich Bio-Gide® when used in extraction sites and alveolar ridge defects with an average vertical defect length and alveolar ridge width up to 5.7 mm and 18 mm, respectively. In many of these studies, the defect was filled with bovine bone mineral before being covered with the collagen membrane under study. After a period of time, the defects were evaluated for new bone growth and defect size. Time to evaluation ranged from 4 months to 10 years, with 4 months being the most common length of time examined. The Bio-Gide collagen membrane successfully performed its intended function by creating space to allow for vertical bone fill to occur and providing better alveolar ridge preservation compared to controls.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
4/5/2022
Geistlich Pharma AG % Roshana Ahmed Sr, Regulatory Specialist TELOS Partners LLC 571 Christina Lake Drive Lakeland, Florida 33813
Re: K212463
Trade/Device Name: Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen and Geistlich Perio-System Combi Pack Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPL. NPM Dated: February 1, 2022 Received: February 1, 2022
Dear Roshana Ahmed:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known) K212463
Device Name
Geistlich Bio-Gide®
Indications for Use (Describe)
Geistlich Bio-Gide® is intended for the following uses:
- · 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
3
510(k) Number (if known) K212463
Device Name
Geistlich Bio-Gide® Compressed
Indications for Use (Describe)
Geistlich Bio-Gide® Compressed is indicated 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.
- · guided tissue regeneration procedures in periodontal defects.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
4
510(k) Number (if known) K212463
Device Name
Geistlich Bio-Gide® Perio
Indications for Use (Describe)
Geistlich Bio-Gide® Perio is intended for the following uses:
- · 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
5
510(k) Number (if known) K212463
Device Name
Geistlich Bio-Gide® Shape
Indications for Use (Describe)
Geistlich Bio-Gide® Shape is indicated 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over The Counter Use (21 CFR 801 Subpart C)
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
6
510(k) Number (if known) K212463
Device Name
Geistlich Combi-Kit Collagen
Geistlich Bio-Gide® is intended for the following uses:
- · 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.
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).
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
7
510(k) Number (if known) K212463
Device Name
Geistlich Perio-System Combi-Pack
Indications for Use (Describe)
Geistlich Bio-Gide® Perio is intended for the following uses:
- · 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.
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).
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
8
510(k) Summary
Geistlich Bio-Gide®
I. Submitter
Geistlich Pharma AG Bahnhofstrasse 40 CH-6110 Wolhusen Switzerland Phone: +41 41 492 55 55
Contact Person: Marco Steiner, Deputy Director Regulatory Affairs Date Prepared: April 5, 2022
II. Device
| Device Proprietary Name: | Geistlich Bio-Gide® |
|---|---|
| Common or Usual Name: | Resorbable Bilayer Membrane for Guided Tissue and Bone |
| Regeneration | |
| Classification Name: | Bone Grafting Material |
| Regulation Number: | 872.3930 |
| Product Code: | NPL |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following device:
- Geistlich Bio-Gide®, K192042, Geistlich Pharma AG ●
IV. Device Description
Geistlich Bio-Gide® is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking and is sterilized by gamma irradiation.
9
Geistlich Bio-Gide® is provided in the following sizes:
- . 13 x 25 mm
- 25 x 25 mm
- 30 x 40 mm
- 40 x 50 mm
Indications for Use V.
Geistlich Bio-Gide® is intended for the following uses:
- 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.
VI. Comparison of Technological Characteristics
The Indications for Use Statement is identical to the predicate device.
The subject device is equivalent to the predicate device with respect to material characteristics, manufacturing and sterilization methods, packaging, and size. Both the subject device and predicate device have equivalent final product specifications. A comparison of the devices is provided in the table below.
Technological comparison
| | Subject Device | Geistlich Bio-Gide®
(K192042) | Analysis |
|---------------|--------------------------------------------------------------------|----------------------------------|--------------------------------------------------|
| Material | Porcine collagen | Identical | The material of
construction is
identical. |
| Sizes | 13 x 25 mm
25 x 25 mm
30 x 40 mm
40 x 50 mm
16 x 22 mm | Substantially equivalent | The offered sizes are
similar. |
| Single-Use | Yes | Identical | Both products are
single-use only. |
| Sterilization | Gamma | Identical | Both products use
gamma irradiation. |
10
The purpose of this submission is to notify the Agency of several minor changes to the product labeling and extension of the product range to include a 30 x 40 mm configuration which falls within the range of size configurations cleared under the predicate device. The differences between the subject and predicate device are addressed by the information provided within this submission.
VII. Performance Data
Non-clinical data was not deemed necessary to support the changes to the product labeling or extension to the product line.
Results from biocompatibility, sterilization, shelf-life, and bench and clinical performance studies from the applicant's own predicate devices (K192042) was leveraged in support of substantial equivalence. The following standards were utilized:
- ISO 10993-2018 ●
- ISO 11137-1:2006 ●
- ISO 11137-2:2013
- ISO 11137-3:2017
Data from fifteen (15) clinical studies involving 297 unique patients covering conditions from dehiscence type defects at dental implant sites to extraction sockets with and without bone resorption support that complete wound closure is not required for Geistlich Bio-Gide® when used in extraction sites and alveolar ridge defects with an average vertical defect length and alveolar ridge width up to 5.7 mm and 18 mm, respectively. In many of these studies, the defect was filled with bovine bone mineral before being covered with the collagen membrane under study. After a period of time, the defects were evaluated for new bone growth and defect size. Time to evaluation ranged from 4 months to 10 years, with 4 months being the most common length of time examined. The Bio-Gide collagen membrane successfully performed its intended function by creating space to allow for vertical bone fill to occur and providing better alveolar ridge preservation compared to controls.
VIII. Conclusion
The subject device is equivalent to the predicate device with respect to intended use and technological characteristics. Therefore, it is concluded that Geistlich Bio-Gide® is substantially equivalent to the identified predicate device.
11
Geistlich Bio-Gide® Shape
I. Submitter
Geistlich Pharma AG Bahnhofstrasse 40 CH-6110 Wolhusen Switzerland Phone: +41 41 492 55 55
Contact Person: Marco Steiner, Deputy Director Regulatory Affairs Date Prepared: April 5, 2022
II. Device
| Device Proprietary Name: | Geistlich Bio-Gide® Shape |
|---|---|
| Common or Usual Name: | Collagen Resorbable Bilayer Membrane |
| Collagen Matrix | |
| Classification Name: | Bone Grafting Material |
| Regulation Number: | 872.3930 |
| Product Code: | NPL |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following device:
- Geistlich Bio-Gide® Shape, K192042, Geistlich Pharma AG ●
IV. Device Description
Geistlich Bio-Gide® Shape is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells into the membrane, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation.
The Geistlich Bio-Gide® Shape membrane has a pre-shaped form with a maximum width and height of 14 mm x 24 mm, respectively.
12
Geistlich Bio-Gide® Shape is indicated 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; and
- guided bone regeneration in dehiscence defects.
Comparison of Technological Characteristics VI.
The Indications for Use Statement is identical to the predicate devices.
The subject device is equivalent to the predicate device with respect to material characteristics, manufacturing and sterilization methods, packaging, and size. Both the subject and predicate device have final product specifications. A comparison of the devices is provided in the table below.
| | Subject Device | Geistlich Bio-Gide®
Shape
(K192042) | Analysis |
|---------------|-------------------------|-------------------------------------------|--------------------------------------------------|
| Material | Porcine collagen | Identical | The material of
construction is
identical. |
| Sizes | 14 x 24 mm (pre-shaped) | Identical | The offered sizes are
identical. |
| Single-Use | Yes | Identical | Both products are
single-use only. |
| Sterilization | Gamma | Identical | Both products use
gamma irradiation. |
oical 1 T
The purpose of this submission is to notify the Agency of several minor changes to the product labeling. The differences between the subject and predicate device are addressed by the information provided within this submission.
are
13
VII. Performance Data
Non-clinical data was not deemed necessary to support the changes to the product labeling.
Results from biocompatibility, sterilization, shelf-life, and bench and clinical performance studies from the applicant's own predicate devices (K192042) was leveraged in support of substantial equivalence. The following standards were utilized:
- ISO 10993-2018 ●
- ISO 11137-1:2006
- ISO 11137-2:2013
- ISO 11137-3:2017
Data from fifteen (15) clinical studies involving 297 unique patients covering conditions from dehiscence type defects at dental implant sites to extraction sockets with and without bone resorption support that complete wound closure is not required for Geistlich Bio-Gide® when used in extraction sites and alveolar ridge defects with an average vertical defect length and alveolar ridge width up to 5.7 mm and 18 mm, respectively. In many of these studies, the defect was filled with bovine bone mineral before being covered with the collagen membrane under study. After a period of time, the defects were evaluated for new bone growth and defect size. Time to evaluation ranged from 4 months to 10 years, with 4 months being the most common length of time examined. The Bio-Gide collagen membrane successfully performed its intended function by creating space to allow for vertical bone fill to occur and providing better alveolar ridge preservation compared to controls.
VIII. Conclusion
The subject device is equivalent to the predicate device with respect to intended use and technological characteristics. Therefore, it is concluded that Geistlich Bio-Gide® Shape is substantially equivalent to the identified predicate device.
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14
Geistlich Bio-Gide® Compressed
I. Submitter
Geistlich Pharma AG Bahnhofstrasse 40 CH-6110 Wolhusen Switzerland Phone: +41 41 492 55 55
Contact Person: Marco Steiner, Deputy Director Regulatory Affairs Date Prepared: April 5, 2022
II. Device
| Device Proprietary Name: | Geistlich Bio-Gide® Compressed |
|---|---|
| Common or Usual Name: | Collagen Resorbable Bilayer Membrane |
| Collagen Matrix | |
| Classification Name: | Bone Grafting Material |
| Regulation Number: | 872.3930 |
| Product Code: | NPL |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following device:
- Geistlich Bio-Gide® Compressed, K192042, Geistlich Pharma AG ●
IV. Device Description
Geistlich Bio-Gide® Compressed is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells into the membrane, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation.
The Geistlich Bio-Gide® Compressed membrane is available in two different sizes, 13 x 25 mm and 20 x 30 mm.
15
Geistlich Bio-Gide® Compressed is indicated 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 teeth.
Comparison of Technological Characteristics VI.
The Indications for Use Statement is identical to the predicate device.
The subject device is equivalent to the predicate device with respect to material characteristics, manufacturing and sterilization methods, packaging, and size. Both the subject and predicate device have equivalent final product specifications. A comparison of the devices is provided in the table below.
| | Subject Device | Geistlich Bio-Gide®
Compressed
(K192042) | Analysis |
|---------------|--------------------------|------------------------------------------------|-----------------------------------------------|
| Material | Porcine collagen | Identical | The material of
construction is identical. |
| Sizes | 13 x 25 mm
20 x 30 mm | Identical | The offered sizes are
identical. |
| Single-Use | Yes | Identical | Both products are
single-use only. |
| Sterilization | Gamma | Identical | Both products use
gamma irradiation. |
Technological comparison
The purpose of this submission is to notify the Agency of several minor changes to the product labeling. The differences between the subject and predicate device are addressed by the information provided within this submission.
16
VII. Performance Data
Non-clinical data was not deemed necessary to support the changes to the product labeling.
Results from biocompatibility, sterilization, shelf-life, and bench and clinical performance studies from the applicant's own predicate devices (K192042) was leveraged in support of substantial equivalence. The following standards were utilized:
- ISO 10993-2018 ●
- ISO 11137-1:2006
- ISO 11137-2:2013
- ISO 11137-3:2017
Data from fifteen (15) clinical studies involving 297 unique patients covering conditions from dehiscence type defects at dental implant sites to extraction sockets with and without bone resorption support that complete wound closure is not required for Geistlich Bio-Gide® when used in extraction sites and alveolar ridge defects with an average vertical defect length and alveolar ridge width up to 5.7 mm and 18 mm, respectively. In many of these studies, the defect was filled with bovine bone mineral before being covered with the collagen membrane under study. After a period of time, the defects were evaluated for new bone growth and defect size. Time to evaluation ranged from 4 months to 10 years, with 4 months being the most common length of time examined. The Bio-Gide collagen membrane successfully performed its intended function by creating space to allow for vertical bone fill to occur and providing better alveolar ridge preservation compared to controls.
VIII. Conclusion
The subject device is equivalent to the predicate device with respect to intended use and technological characteristics. Therefore, it is concluded that Geistlich Bio-Gide® Compressed is substantially equivalent to the identified predicate device.
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17
Geistlich Bio-Gide® Perio
I. Submitter
Geistlich Pharma AG Bahnhofstrasse 40 CH-6110 Wolhusen Switzerland Phone: +41 41 492 55 55
Contact Person: Marco Steiner, Deputy Director Regulatory Affairs Date Prepared: April 5, 2022
II. Device
| Device Proprietary Name: | Geistlich Bio-Gide® Perio |
|---|---|
| Common or Usual Name: | Collagen Resorbable Bilayer Membrane |
| Classification Name: | Bone Grafting Material |
| Regulation Number: | 872.3930 |
| Product Code: | NPL |
| Device Classification: | II |
III. Predicate Device
Substantial equivalence is claimed to the following device:
- Geistlich Bio-Gide® Perio, K192042, Geistlich Pharma AG ●
IV. Device Description
Geistlich Bio-Gide® Perio is a pure collagen membrane with a bilayer structure and smoothed dense (cell-occlusive) surface. The modified surface makes the membrane somewhat stiffer in the dry state, and this facilitates cutting the membrane for periodontal applications. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation.
Pre-formed sterile templates are provided to simplify the cutting of the respective membrane shape. Four templates (uncoated Tyvek®) are packaged with Geistlich Bio-Gide® Perio to serve as an aid to assist the clinician in trimming the Geistlich Bio-Gide® Perio membrane to fit the defect and are in varying shapes to fit the clinical need (e.g., rectangular, interproximal). The templates are packaged as an accessory product with Geistlich Bio-Gide® Perio.
18
Geistlich Bio-Gide® Perio is intended for the following uses:
- 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.
Comparison of Technological Characteristics VI.
The Indications for Use Statement is identical to the predicate device.
The subject device is equivalent to the predicate device with respect to material characteristics, manufacturing and sterilization methods, packaging, and size. Both the subject and predicate device have equivalent final product specifications. A comparison of the devices is provided in the table below.
| | Subject Device | Geistlich Bio-Gide®
Perio
(K192042) | Analysis |
|---------------|------------------|-------------------------------------------|--------------------------------------------|
| Material | Porcine collagen | Identical | The material of construction is identical. |
| Sizes | 16 x 22 mm | Identical | The offered sizes are identical. |
| Single-Use | Yes | Identical | Both products are single-use only. |
| Sterilization | Gamma | Identical | Both products use gamma irradiation. |
Technological comparison
The purpose of this submission is to notify the Agency of several minor changes to the product labeling. The differences between the subject and predicate device are addressed by the information provided within this submission.
19
VII. Performance Data
Non-clinical data was not deemed necessary to support the changes to the product labeling.
Results from biocompatibility, sterilization, shelf-life, and bench and clinical performance studies from the applicant's own predicate devices (K192042) was leveraged in support of substantial equivalence. The following standards were utilized:
- ISO 10993-2018 ●
- ISO 11137-1:2006
- ISO 11137-2:2013
- ISO 11137-3:2017
Data from fifteen (15) clinical studies involving 297 unique patients covering conditions from dehiscence type defects at dental implant sites to extraction sockets with and without bone resorption support that complete wound closure is not required for Geistlich Bio-Gide® when used in extraction sites and alveolar ridge defects with an average vertical defect length and alveolar ridge width up to 5.7 mm and 18 mm, respectively. In many of these studies, the defect was filled with bovine bone mineral before being covered with the collagen membrane under study. After a period of time, the defects were evaluated for new bone growth and defect size. Time to evaluation ranged from 4 months to 10 years, with 4 months being the most common length of time examined. The Bio-Gide collagen membrane successfully performed its intended function by creating space to allow for vertical bone fill to occur and providing better alveolar ridge preservation compared to controls.
VIII. Conclusion
The subject device is equivalent to the predicate device with respect to intended use and technological characteristics. Therefore, it is concluded that Geistlich Bio-Gide® Perio is substantially equivalent to the identified predicate device.
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20
Geistlich Combi-Kit Collagen
I. Submitter
Geistlich Pharma AG Bahnhofstrasse 40 CH-6110 Wolhusen Switzerland Phone: +41 41 492 55 55
Contact Person: Marco Steiner, Deputy Director Regulatory Affairs Date Prepared: April 5, 2022
II. Device
| Device Proprietary Name: | Geistlich Combi-Kit Collagen |
|---|---|
| Common or Usual Name: | Collagen Resorbable Bilayer Membrane |
| Collagen Matrix | |
| Classification Name: | Bone Grafting Material |
| Regulation Number: | 872.3930 |
| Product Code: | NPM/NPL |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following device:
- Geistlich Combi-Kit Collagen, K192042, Geistlich Pharma AG ●
IV. Device Description
Geistlich Combi-Kit Collagen is a convenience kit containing one unit of Geistlich Bio-Oss Collagen® and one unit of Geistlich Bio-Gide®. The two devices are packaged in double blisters in one package and then sterilized by gamma irradiation.
Geistlich Bio-Oss Collagen® is a combination of purified spongiosa (cancellous) natural bone mineral granules and 10% collagen fibers in a block form (100 mg) and is sterilized by gamma irradiation.
Geistlich Bio-Gide® is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the
21
soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking and is sterilized by gamma irradiation.
The size of the Geistlich Bio-Gide® bilayer membrane to be provided in the Geistlich Combi-Kit Collagen convenience kit is 16 mm x 22 mm.
V. Indications for Use
Geistlich Bio-Gide® is intended for the following uses:
- 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.
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).
VI. Comparison of Technological Characteristics
The Indications for Use Statement is identical to the predicate device.
The subject device is equivalent to the predicate device with respect to materials characteristics, manufacturing and sterilization methods, packaging, and size. Both the subject and predicate device have equivalent final product specifications. A comparison of the devices is provided in the table below.
22
| | Subject Device | Predicate Device
(K192042) | Analysis |
|---------------|----------------------------------------------------|-------------------------------|--------------------------------------------|
| Format | Convenience Kit | Identical | Both products are
convenience kits. |
| Kit Contents | Geistlich Bio-Oss Collagen®
Geistlich Bio-Gide® | Identical | The contents of the kits
are identical. |
| Sizes | Geistlich Bio-Gide®: 16 x 22 mm | Identical | The product sizes are
identical. |
| Single-Use | Yes | Identical | Both products are
single-use only. |
| Sterilization | Gamma | Identical | Both products are
gamma sterilized. |
The purpose of this submission is to notify the Agency of several minor changes to the product labeling. The differences between the subject and predicate device are addressed by the information provided within this submission.
VII. Performance Data
Non-clinical data was not deemed necessary to support the changes to the product labeling.
Results from biocompatibility, sterilization, shelf-life, and bench and clinical performance studies from the applicant's own predicate devices (K192042) was leveraged in support of substantial equivalence. The following standards were utilized:
- ISO 10993-2018
- ISO 11137-1:2006
- ISO 11137-2:2013 ●
- ISO 11137-3:2017 ●
Data from fifteen (15) clinical studies involving 297 unique patients covering conditions from dehiscence type defects at dental implant sites to extraction sockets with and without bone resorption support that complete wound closure is not required for Geistlich Bio-Gide® when used in extraction sites and alveolar ridge defects with an average vertical defect length and alveolar ridge width up to 5.7 mm and 18 mm, respectively. In many of these studies, the defect was filled with bovine bone mineral before being covered with the collagen membrane under study. After a period of time, the defects were evaluated for new bone growth and defect size. Time to evaluation ranged from 4 months to 10 years, with 4 months being the most common length of time examined. The Bio-Gide collagen membrane successfully performed its intended function by creating space to allow for vertical bone fill to occur and providing better alveolar ridge preservation compared to controls.
23
VIII. Conclusion
The subject device is equivalent to the predicate device with respect to intended use and technological characteristics. Therefore, it is concluded that Geistlich Combi-Kit Collagen is substantially equivalent to the identified predicate device.
24
Geistlich Perio-System Combi-Pack
I. Submitter
Geistlich Pharma AG Bahnhofstrasse 40 CH-6110 Wolhusen Switzerland Phone: +41 41 492 55 55
Contact Person: Marco Steiner, Deputy Director Regulatory Affairs Date Prepared: April 5, 2022
II. Device
| Device Proprietary Name: | Geistlich Perio-System Combi Pack |
|---|---|
| Common or Usual Name: | Collagen Resorbable Bilayer Membrane |
| Collagen Matrix | |
| Classification Name: | Bone Grafting Material |
| Regulation Number: | 872.3930 |
| Product Code: | NPM/NPL |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following devices:
- Geistlich Perio-System Combi Pack, K192042, Geistlich Pharma AG ●
IV. Device Description
Geistlich Perio-System Combi-Pack is a convenience kit containing one unit of Geistlich Bio-Oss Collagen® and one unit of Geistlich Bio-Gide® Perio. Geistlich Bio-Oss Collagen® (sold either as an individual unit or as one of the components of Geistlich Perio-System Combi-Pack) is a combination of purified spongiosa (cancellous) natural bone mineral granules and 10% collagen fibers in a block form (100 mg) and is sterilized by gamma irradiation.
Geistlich Bio-Gide® Perio (sold either as an individual unit or as one of the components of Geistlich Perio-System Combi-Pack) is a pure collagen membrane with a bilayer structure and smoothed dense (cell-occlusive) surface. The modified surface makes the membrane somewhat stiffer in the dry state, and this facilitates cutting the membrane for periodontal applications. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense
25
surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the defect. The membrane is made of collagen without further cross-linking and is sterilized by gamma irradiation. The size of the Geistlich Bio-Gide® Perio bilayer membrane to be provided in the Geistlich Perio-System Combi-Pack convenience kit and as individual units is 16 mm x 22 mm.
Preformed sterile templates are provided to simplify the cutting of the respective membrane shape. Four templates (uncoated Tyvek®) are packaged with Geistlich Bio-Gide® Perio to serve as an aid to assist the clinician in trimming the Geistlich Bio-Gide® Perio membrane to fit the defect, and are in varying shapes to fit the clinical need (e.g., rectangular, interproximal). The templates are packaged as an accessory product with Geistlich Bio-Gide® Perio.
Indications for Use V.
Geistlich Bio-Gide® Perio is intended for the following uses:
- 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.
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).
VI. Comparison of Technological Characteristics
The Indications for Use Statement is identical to the predicate device.
The subject device is equivalent to the predicate device with respect to materials characteristics, manufacturing and sterilization methods, packaging, and size. Both the subject and predicate device have equivalent final product specifications. A comparison of the subject and predicate device is provided in the table below.
26
| | Subject Device | Predicate Device
(K192042) | Analysis |
|---------------|----------------------------------------------------------|-------------------------------|--------------------------------------------|
| Format | Convenience Kit | Identical | Both products are
convenience kits. |
| Kit Contents | Geistlich Bio-Oss Collagen®
Geistlich Bio-Gide® Perio | Identical | The contents of the
kits are identical. |
| Sizes | Geistlich Bio-Gide® Perio: 16 x 22 mm | Identical | The product sizes are
identical. |
| Single-Use | Yes | Identical | Both products are
single-use only. |
| Sterilization | Gamma | Identical | Both products are
gamma sterilized. |
The purpose of this submission is to notify the Agency of several minor changes to the product labeling. The differences between the subject and predicate device are addressed by the information provided within this submission.
VII. Performance Data
Non-clinical data was not deemed necessary to support the changes to the product labeling.
Results from biocompatibility, sterilization, shelf-life, and bench and clinical performance studies from the applicant's own predicate devices (K192042) was leveraged in support of substantial equivalence. The following standards were utilized:
- ISO 10993-2018 ●
- . ISO 11137-1:2006
- ISO 11137-2:2013 ●
- ISO 11137-3:2017 ●
Data from fifteen (15) clinical studies involving 297 unique patients covering conditions from dehiscence type defects at dental implant sites to extraction sockets with and without bone resorption support that complete wound closure is not required for Geistlich Bio-Gide® when used in extraction sites and alveolar ridge defects with an average vertical defect length and alveolar ridge width up to 5.7 mm and 18 mm, respectively. In many of these studies, the defect was filled with bovine bone mineral before being covered with the collagen membrane under study. After a period of time, the defects were evaluated for new bone growth and defect size. Time to evaluation ranged from 4 months to 10 years, with 4 months being the most common length of time examined. The Bio-Gide collagen membrane successfully performed its intended function by creating space to allow for vertical bone fill to occur and providing better alveolar ridge preservation compared to controls.
27
VIII. Conclusion
The subject device is equivalent to the predicate device with respect to intended use and technological characteristics. Therefore, it is concluded that Geistlich Perio-System Combi-Pack is substantially equivalent to the identified predicate device.
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